Cookie policy
This website www.meddevsolutions.co.uk uses Cookies and similar technologies in order to distinguish you from other users. By using Cookies, We are able to provide you with a better experience and to improve Our Site by better understanding how you use it. Please read this Cookie Policy carefully and ensure that you understand it. Your acceptance of Our Cookie Policy is deemed to occur when you press the “accept” button on Our Cookie banner or when you have selected your preferred Cookie options in Our Cookie manager and pressed the “Continue” button. If you do not agree to Our Cookie Policy, please stop using Our Site immediately.
1. Definitions and Interpretation
In this Cookie Policy, unless the context otherwise requires, the following expressions have the following meanings:
Cookie: means a small file placed on your computer or device by Our Site when you visit certain parts of Our Site and/or when you use certain features of Our Site;
Cookie Law: means the relevant parts of the Privacy and Electronic Communications (EC Directive) Regulations 2003 and of EU Regulation 2016/679 General Data Protection Regulation (“GDPR”);
Personal data: means any and all data that relates to an identifiable person who can be directly or indirectly identified from that data, as defined by EU Regulation 2016/679 General Data Protection Regulation (“GDPR”); and
We/Us/Our: means “Our Website/School/Company”, the brand owned and operated by Company name or Person.
2. Information About Us
Our Site is owned and operated by Company name or person(s).
- Registered address: Meddev Solutions Ltd, River House, Home Avenue, Newry, BT34 2DL
- Email address: your email
- Telephone number: your phone
3. How Does Our Site Use Cookies?
- 3.1 Our Site may place and access certain first-party Cookies on your computer or device. First party Cookies are those placed directly by Us and are used only by Us. We use Cookies to facilitate and improve your experience of Our Site and services. We have carefully chosen these Cookies and have taken steps to ensure that your privacy and personal data is protected and respected at all times.
- 3.2 By using Our Site, you may also receive certain third-party Cookies on your computer or device. Third-party Cookies are those placed by websites, services, and/or parties other than Us. Third-party Cookies are used on Our Site for analytics and for marketing purposes. For more details, please refer to section 4 below.
- 3.3 All Cookies used by and on Our Site are used in accordance with current Cookie Law. We may use some or all of the following types of Cookie:
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3.3.1 Strictly Necessary Cookies
A Cookie falls into this category (usually first-party cookies) if it is essential to the operation of Our Site as without them we cannot provide the functionality that you need to use this website. For example, essential cookies help remember your preferences as you navigate through the online school, also support functions such as logging in, and payment transactions. -
3.3.2 Functionality Cookies
Functional Cookies allow our web site to remember choices you make, e.g. your user name, log in details and language preferences and any customizations you make to pages during your visit. They are necessary to provide features and services specific to individual users. -
3.3.3 Analytics Cookies
It is important for Us to understand how you use Our Site, for example, how efficiently you are able to navigate around it, and what features you use. Analytics Cookies enable us to gather this information, helping Us to improve Our Site and your experience of it. -
3.3.4 Marketing/Targeting Cookies
It is important for Us to know when and how often you visit Our Site, and which parts of it you have used (including which pages you have visited and which links you have visited). As with analytics Cookies, this information helps us to better understand you and, in turn, to make Our Site and advertising more relevant to your interests. Some information gathered by targeting Cookies may also be shared with third parties. -
3.3.5 Third Party Cookies
Third-party Cookies are not placed by Us; instead, they are placed by third parties that provide services to Us and/or to you. Third-party Cookies may be used by advertising services to serve up tailored advertising to you on Our Site, or by third parties providing analytics services to Us (these Cookies will work in the same way as analytics Cookies described above). -
3.3.6 Persistent Cookies
Any of the above types of Cookie may be a persistent Cookie. Persistent Cookies are those which remain on your computer or device for a predetermined period and are activated each time you visit Our Site. -
3.3.7 Session Cookies
Any of the above types of Cookie may be a session Cookie. Session Cookies are temporary and only remain on your computer or device from the point at which you visit Our Site until you close your browser. Session Cookies are deleted when you close your browser.
- 3.4 Cookies on Our Site are not permanent and will expire as indicated in the table below.
- 3.5 For more details of the personal data that We collect and use, the measures we have in place to protect personal data, your legal rights, and our legal obligations, please refer to our Privacy Policy
- 3.6 For more specific details of the Cookies that We use, please refer to the table below.
4. What Cookies Does Our Site Use?
- 4.1 The following first-party Cookies may be placed on your computer or device:
Name of Cookie | Purpose | Strictly Necessary | Expires |
XSRF-TOKEN | Preserves User Login information and states | Yes | When you close your browser |
DPSettings | Preserves the user's Cookie policy preferences | Yes | 12 days |
slim_session | Preserves User Login information and states | Yes | 1 day |
- 4.2 The following strictly necessary third-party Cookies may be placed on your computer or device (remove stripe cookies from the list if you don’t use stripe):
Name of Cookie | Provider | Purpose | Expires |
nsr | m.stripe.network | Used to process payments for our website. | When you close your browser |
cookiesEnabled | checkout.stripe.com | Used to process payments for our website. | When you close your browser |
__stripe_sid | checkout.stripe.com | Used to process payments for our website. | When you close your browser |
__stripe_mid | checkout.stripe.com | Used to distinguish users. | 1 year |
ab_disable_remember_ | checkout.stripe.com | Used to process payments for our website. | 7 years |
checkout-test-session | checkout.stripe.com | Used to process payments for our website. | 10 years |
cid | checkout.stripe.com | Used to process payments for our website. | for ever |
vuid | vimeo.com | These cookies are used by Vimeo to collect analytics tracking information. | 1 year |
player | player.vimeo.com | These cookies are used by Vimeo to collect analytics tracking information. | 1 year |
- 4.3 Our Site uses the following functional Cookies (remove cookies not exploited in your school):
Olark
Name of Cookie | Provider | Purpose | Expires |
hblid | www.meddevsolutions.co.uk | a visitor identifier that we use only on your site to remember this visitor between visits | 2 years |
wcsid | www.meddevsolutions.co.uk | a session identifier that we use only on your site to keep track of a single chat session | When you close your browser |
olfsk | www.meddevsolutions.co.uk | storage identifier that we use to maintain chat state across pages (e.g. message history) | 2 years |
_okbk | www.meddevsolutions.co.uk | extra state information (e.g. chat box being open/closed) | When you close your browser |
_ok | www.meddevsolutions.co.uk | most recent Olark site ID (security measure) | When you close your browser |
_oklv | www.meddevsolutions.co.uk | the Olark loader version (for improved caching) | When you close your browser |
_okla | www.meddevsolutions.co.uk | used for caching purposes (loaded from CDN vs. loaded from our infrastructure) | When you close your browser |
_okgid | www.meddevsolutions.co.uk | used for caching by setting a hash for assets to determine if they have changed and if they need to be refreshed | When you close your browser |
_okac | www.meddevsolutions.co.uk | used for caching by setting a hash for assets to determine if they have changed and if they need to be refreshed | When you close your browser |
TawkTo
Name of Cookie | Provider | Purpose | Expires |
TawkConnectionTime | www.meddevsolutions.co.uk | previous registration time stamp | When you close your browser |
Tawk_ | www.meddevsolutions.co.uk | socket connection url | When you close your browser |
__tawkuuid | www.meddevsolutions.co.uk | domain restriction values | 6 months |
__cfduid | tawk.to | Used by the content network, Cloudflare, to identify trusted web traffic. | 1 year |
Freshchat
Name of Cookie | Provider | Purpose | Expires |
pubsub_cookie | www.meddevsolutions.co.uk | This cookie is used for the freshchat service | When you close your browser |
hop- | www.meddevsolutions.co.uk | This cookie is used for the freshchat service | When you close your browser |
www.meddevsolutions.co.uk | This cookie is used for the freshchat service | When you close your browser | |
_ | www.meddevsolutions.co.uk | This cookie is used for the freshchat service | 1 year |
pnctest | www.meddevsolutions.co.uk | This cookie is used for the freshchat service | 1 year |
Zendesk Web Widget
Name of Cookie | Provider | Purpose | Expires |
ZD-referrerPolicy | www.meddevsolutions.co.uk | Stores referrer tags | Forever |
ZD-zE_oauth | www.meddevsolutions.co.uk | Stores the authentication token once the user has been authenticated. | 2 hours |
ZD-currentTime | www.meddevsolutions.co.uk | Sets the time when page loads. | Forever |
ZD-settings | www.meddevsolutions.co.uk | Stores a hash of settings so that we don't keep sending blips after the initial one | Forever |
ZD-suid | www.meddevsolutions.co.uk | Session id for pathfinder. | 20 minutes |
ZD-buid | www.meddevsolutions.co.uk | Collects Machine ID. | Forever |
Intercom
Name of Cookie | Provider | Purpose | Expires |
intercom-id- | www.meddevsolutions.co.uk | This cookie is used by Intercom as a session so that users can continue a chat as they move through the site. | 9 months |
- 4.4 Our Site uses analytics services provided by your analytics services, if any. Website analytics refers to a set of tools used to collect and analyse anonymous usage information, enabling us to better understand how Our Site is used. This, in turn, enables us to improve Our Site and the products and services offered through them.
- 4.5 The analytics services used by Our Site use Cookies to gather the required information. You do not have to allow us to use these Cookies, however, whilst our use of them does not pose any risk to your privacy or your safe use of Our Site, it does enable us to continually improve Our Site, making it a better and more useful experience for you.
- 4.6 The analytics services used by Our Site uses the following Cookies (remove cookies not exploited in your school):
Google Analytics
Name of Cookie | Provider | Purpose | Expires |
_ga | www.meddevsolutions.co.uk | Google Analytics: Registers a unique ID that is used to generate statistical data on how the visitor uses the website. | 2 years |
_gat | www.meddevsolutions.co.uk | Google Analytics: Used by Google Analytics to throttle the request rate. | When you close your browser |
_gid | www.meddevsolutions.co.uk | Google Analytics: Registers a unique ID that is used to generate statistical data on how the visitor uses the website. | When you close your browser |
collect | www.meddevsolutions.co.uk | Google Analytics: Used to send data to Google Analytics about the visitor's device and behaviour. Tracks the visitor across devices and marketing channels. | When you close your browser |
Mixpanel
Name of Cookie | Provider | Purpose | Expires |
mp_#_mixpanel | www.meddevsolutions.co.uk | MixPanel: Cookie used by MixPanel for analytics purposes | 1 year |
Sumo me
Name of Cookie | Provider | Purpose | Expires |
__smToken | www.meddevsolutions.co.uk | The __smToken is set once you login to Sumo and is checked to verify whether you are logged into Sumo or not. | 1 year |
__smSmartbarShown | www.meddevsolutions.co.uk | Is set when the Smartbar is shown | 50 years |
__smVID | www.meddevsolutions.co.uk | Used to display relevant advertising | 1 month |
__smSessionId | www.meddevsolutions.co.uk | Used by Sumo to establish a cookie on a users computer to begin a session to enable Sumo products | When you close your browser |
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4.7 Targeting/Marketing cookies
Targeting/Marketing cookies are used to track visitors across websites. They may be used by those companies to build a profile of your interests and show you relevant adverts on other sites. They do not store directly personal information but are based on uniquely identifying your browser and internet device. The intention is to display ads that are relevant and engaging for the individual user and thereby more valuable for publishers and third-party advertisers. If you do not allow these cookies, you will experience less targeted advertising (remove cookies not exploited in your school):
Name of Cookie | Provider | Purpose | Expires |
fr | facebook.com | Used by Facebook to deliver a series of advertisement products such as real time bidding from third-party advertisers | 3 months |
fr | facebook.com | Used by Facebook to deliver a series of advertisement products such as real time bidding from third-party advertisers | When you close your browser |
Hubspot
Name of Cookie | Provider | Purpose | Expires |
__hstc | www.meddevsolutions.co.uk | The main cookie for tracking visitors. It contains the domain, utk (see below), initial timestamp (first visit), last timestamp (last visit), current timestamp (this visit), and session number (increments for each subsequent session). | 2 years |
hubspotutk | www.meddevsolutions.co.uk | This cookie is used for to keep track of a visitor's identity. This cookie is passed to HubSpot on form submission and used when de-duplicating contacts. | 10 years |
__hssc | www.meddevsolutions.co.uk | This cookie keeps track of sessions. This is used to determine if we should increment the session number and timestamps in the __hstc cookie. It contains the domain, viewCount (increments each pageView in a session), and session start timestamp. | 30 min |
__hssrc | www.meddevsolutions.co.uk | Whenever HubSpot changes the session cookie, this cookie is also set. We set it to 1 and use it to determine if the visitor has restarted their browser. If this cookie does not exist when we manage cookies, we assume it is a new session. | session |
messagesUtk | www.meddevsolutions.co.uk | This cookie is used to recognize visitors who chat with you via the messages tool. If the visitor leaves your site before they're added as a contact, they will have this cookie associated with their browser. If you have a history of chatting with a visitor and they return to your site later in the same cookied browser, the messages tool will load your conversation history with that visitor. | session |
Refersion
Name of Cookie | Provider | Purpose | Expires |
ci_session | refersion.com | Preserves users states across page requests. | When you close your browser |
refersion_csrf_code | refersion.com | Sets csrf token to prevent cross site request forgery. | When you close your browser |
__cfduid | refersion.com | Used by the content network, Cloudflare, to identify trusted web traffic. | 1 year |
Google AdWords
Name of Cookie | Provider | Purpose | Expires |
ads/ga-audiences | www.meddevsolutions.co.uk | Used by Google AdWords to re-engage visitors that are likely to convert to customers based on the visitor's online behaviour across websites. | When you close your browser |
Fomo
Name of Cookie | Provider | Purpose | Expires |
Fomo.hstry-count-since-first-event- | www.meddevsolutions.co.uk | Used by Fomo for showing user notifications. | Persistent |
Fomo.hstry-first-timestamp- | www.meddevsolutions.co.uk | Used by Fomo for showing user notifications | Persistent |
Fomo.snv- | www.meddevsolutions.co.uk | Used by Fomo for showing user notifications | Persistent |
5. Consent and Control
(Keep section 5.1 and 5.2 if you are using our cookie opt-in mechanism from School Privacy settings.)
- 5.1 Before Cookies are placed on your computer or device, you will be shown a banner requesting your consent to set those Cookies. By giving your consent to the placing of Cookies you are enabling Us to provide the best possible experience and service to you. You may, if you wish, deny consent to the placing of Cookies unless those Cookies are strictly necessary; however certain features of Our Site may not function fully or as intended. You will be given the opportunity to allow and/or deny different categories of Cookie that We use.
- 5.2 In addition to the controls that We provide, you can choose to enable or disable Cookies in your internet browser. Most internet browsers also enable you to choose whether you wish to disable all Cookies or only third-party Cookies. By default, most internet browsers accept Cookies but this can be changed. For further details, please consult the help menu in your internet browser or the documentation that came with your device.
- 5.3 The links below provide instructions on how to control Cookies in all mainstream browsers:
- 5.3.1 Google Chrome
- 5.3.2 Microsoft Internet Explorer
- 5.3.3 Microsoft Edge (Please note that there are no specific instructions at this time, but Microsoft support will be able to assist)
- 5.3.4 Safari (macOS)
- 5.3.5 Safari (iOS)
- 5.3.6 Mozilla Firefox
- 5.3.7 Android (Please refer to your device’s documentation for manufacturers’ own browsers)
6. Changes to this Cookie Policy
- 6.1 We may alter this Cookie Policy at any time. Any such changes will become binding on you on your first use of Our Site after the changes have been made. You are therefore advised to check this page from time to time.
- 6.2 In the event of any conflict between the current version of this Cookie Policy and any previous version(s), the provisions current and in effect shall prevail unless it is expressly stated otherwise.
7. Further Information
- 7.1 If you would like to know more about how We use Cookies, please contact Us at info@meddevsolutions.co.uk.
- 7.2 For more information about privacy, data protection and our terms and conditions, please visit the following:
- 7.2.1 Privacy Policy
- 7.2.1 Terms & Conditions
We provide industry-leading training and consultancy solutions for the medical device industry.
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Copyright © Meddev Solutions Ltd 2023
Katie Cooney
Katie has a passion for developing people and the organisations they work for by identifying, designing and delivering the right training solutions at the right time, for right people.
Katie holds a bachelor’s degree in Personnel Management, an Advanced Diploma in Personal Leadership and executive coaching and a CIPD award in Designing Digital and Blended Learning.
Katie has over 15 years of experience across a variety of roles including Operations Trainer, Training Coordinator, Learning and Development Specialist, Senior Training Supervisor and Global LMS Specialist. All experience has been gained within Multinational Manufacturing including Medical Device, Pharmaceuticals and Automotive.
Katie understands the businesses we support and has gained experience in Audits, CAPA Management, Quality Management Systems and Lean Six Sigma. Katie has expertise in Learning Management Systems, Training Needs Analysis, Training Design, Delivery, and Evaluation to name a few. Together with our bank of experienced SMEs and Consultants makes her the perfect collaborator in making Meddev Solutions the number 1 trusted partner for training.
Rod Beuzeval
Rod brings a wealth of worldwide regulatory knowledge and quality assurance experience to companies wanting to design, manufacture, and market compliant medical devices.
Rod has a bachelor’s degree with first class honours in engineering and management. He also holds the prestigious Regulatory Affairs Certification (Global Scope) from the Regulatory Affairs Professionals Society and is a Lean Sigma Green Belt. Rod has worked in the medical device and pharmaceutical industry for over 22 years, including some of the largest medical device and pharmaceutical manufacturers.
Rod’s experience has involved providing regulatory strategy from product development to worldwide market registration, creation of technical documentation, implementation of full 13485 compliant QMS systems, standards compliance, clinical evaluations, risk management files, project management and remediation activities. Rod has also spent time working for a notified body, conducting audits against EN ISO 13485 on medical device manufacturers around Europe, and supporting reviews of technical documentation.
Abbie Ambridge
Abbie has worked within the medical device sector since 2015 and has managed the marketing activities at Meddev Solutions since 2017.
Abbie discovered a key passion for marketing whilst completing her business studies diploma and went on to continue this passion by studying professional marketing at the Chartered Institute of Marketing.
Abbie now oversees our content marketing, web design, and SEO activities to achieve better visibility and enhance brand reach. She coordinates marketing campaigns, from social media advertising to print design and e-shots.
She’s always on hand to give advice on how to use various marketing tools to contribute to the bottom line.
She’s always on hand to give advice on how to use various marketing tools to contribute to the bottom line.
Hoss Ghasemi
With over two decades of hands-on experience, Hoss stands out as a seasoned Learning Experience Designer, eLearning Specialist, and L&D Consultant, overseeing the full spectrum of the learning and training journey.
His prowess encompasses everything from Learning Needs Analysis and strategic blueprinting to storyboarding, design, development, and the delivery and assessment phases — all tailored to prioritize learner-centric solutions.
His prowess encompasses everything from Learning Needs Analysis and strategic blueprinting to storyboarding, design, development, and the delivery and assessment phases — all tailored to prioritize learner-centric solutions.
Equipped with dual degrees in Artificial Intelligence and Learning Technology, Hoss possesses a profound ability to integrate Learning Theories and the Design Thinking methodology. This ensures the learning experiences he crafts align seamlessly with user psychology, critical business metrics, commercial ingenuity, and forward-thinking innovation.
Beyond his notable contributions to the pharmaceutical sector, Hoss’s versatility is evident in his extensive professional engagements across diverse industries. This list includes IT, Consulting, Banking & Finance, HR, Engineering, Software & Hardware, High-tech, Oil & Energy, FMCG, Food, FinTech, Telecommunications, Military & Defence, Healthcare, Media & Entertainment, Retail, Aviation, Marketing, and Higher Education.
Colm O'Rourke
Colm is a quality and regulatory consultant and trainer, with a focus on European medical device and in-vitro diagnostic medical device regulations.
Colm has over 10 years’ experience in a range of areas including clinical laboratories, point-of-care in-vitro diagnostics companies and a European Notified Body. Colm has held roles as a medical scientist, in point-of-care clinical applications, business development and industry engagement.
Colm has supported several medical device start-up companies through accelerator and innovation programs in the area of regulatory strategy and was a member of the internal Notified Body designation team for both the MDR and IVDR.
During the COVID-19 Pandemic, Colm was part of the standards team that developed SWiTF 19:2020 Barrier masks for consumers – Requirements.
During the COVID-19 Pandemic, Colm was part of the standards team that developed SWiTF 19:2020 Barrier masks for consumers – Requirements.
Colm has a BSc (Hons) in Biomedical Science from University College Cork, Ireland and a Diploma in Medical Device Science from the University of Galway, Ireland.
Rachel Hattersley-Dykes
Rachel is an accomplished Medical Writer, Reviewer and Manager with extensive writing and reviewing experience.
Rachel is a registered Nurse with over 15 years of experience in the clinical space and has worked on all aspects of clinical evaluation. Rachel has considerable experience working with different manufacturers across a range of therapeutic areas and focuses on the practical application of the regulation and the tools required to successfully conduct clinical evaluations.
Rachel has overseen the medical review of all advertising materials for a large medical device organisation and delivered a project to improve review timelines and consistency. Rachel helped to develop a master harms lists to ensure consistent, compliant claims reporting and established the new role of technical lead to deliver a large CER consultancy project to meet EU MDR requirements. Rachel has been delivering training courses on clinical evaluation and PMCF on TOPRA for over 5 years.
Rachel has a BSc (hons) in Nursing and is currently undertaking a Master’s degree in Psychology at the University of Chester.
Hannah Quinn
Hannah is the Marketing Executive at Meddev Solutions and is based in Galway, Ireland.
She previously worked as a freelance copywriter and Spanish to English translator, helping businesses embrace their online presence and attract their ideal clients through websites and social media.
Hannah holds a bachelor’s degree in Spanish, Sociology and Politics, as well as an MA in Spanish. With a diploma in copywriting from the College of Media and Publishing and multiple digital marketing certifications under her belt, Hannah harnesses her unique professional experiences to develop herself further in a new industry.
Committed to professional development, she will soon be undertaking a Certificate in Digital Media and Marketing at Atlantic Technological University.
Theresa Jeary
Theresa holds a master’s degree in Pharmaceutical Science from the Royal College of Surgeons, Ireland and is eligible to be a Pharmaceutical Qualified Person.
Theresa has over 30 years’ experience working in both the Pharmaceutical and Medical Device industries and has worked in a variety of roles across the full development cycle from product concept and early stage development, process transfer, validation and regulatory departments.
In addition to her product development and global regulatory expertise, Theresa has over 12 years Notified Body experience, first at BSI as a technical expert for devices with ancillary medicinal substance and borderline classifications moving then to LRQA where she held the role of Head of Notified Body for several years.
More recently Theresa has worked as a consultant to the Medtech sector assisting Manufacturers in their product development and supporting them in navigating their legal requirements and changes to the Medical Device Regulations.
Theresa is a regular presenter on combination products and Article 117 and regularly contributes to various scientific publications and regulatory guidance and has extensive experience of interacting with EU Competent Authorities.
Niamh Lynch
Niamh brings 30-years’ global quality & regulatory experience and knowledge spanning Software Engineering, Database Technologies and Artificial Intelligence. Niamh started work in the UK as a Systems Engineer following completion of BSc (Hons) Cognitive Science (Artificial Intelligence) implementing SAP R/3 ERP Software System to multinational companies across Europe, before going to Basil, Switzerland to live and work with Novartis Pharmaceutical.
On returning to Galway, Niamh’s native county, she moved into the medical devices, pharmaceutical, combination and active devices including in vitro diagnostic systems/software providing with responsibility for automated software systems under GAMP4 and GAMP5.
Niamh has amassed extensive knowledge & experience over 20+ years’ in the life sciences, leading Design Control, Risk Management and Computer System Validation and Regulatory Teams to successful regulatory acceptance for companies such as Boston Scientific, Merit Medical, Johnson & Johnson, Mylan and Olympus. Her experience spans greenfield sites, start-ups, medium and multi-national organisations before moving to Regulatory Body.
Niamh became a leading risk and software trainer as a lead technical CE mark reviewer for NSAI Medical Device Notified Body specialising in MDR, Risk Management, Software & New Technologies, including Active Devices under IEC 60601 & IEC 62304. Niamh supported the 1st generation guidance for SaMD developed by the MDCG New Technology Group set-up by the EU Commission for identification of software requirements related to healthcare applications and new emerging technologies (AI).
Niamh is a certified Lead QMS Auditor with extensive knowledge of state of the art, risk management, product development and regulatory requirements with regulatory submissions in US, EU/UK, CA and Japan including MDSAP Certification. Niamh is a member of Engineering Ireland and holds a Master’s in Software Engineering and Database Technologies, MScSED (1:1).
Niamh is currently the Director of Regulatory Affairs and Quality for active medical device with embedded software and software accessory/component application.
Aaron Snyder
Wayne Aaron Snyder is a GxP Quality Assurance Leader with extensive experience of leading quality assurance teams and providing training to the industry on cGMPs.
Aaron has worked in the medical device industry for the last 20 years, working at some of the biggest medical device manufactures taking on positions of increasing responsibilities for Quality and Regulatory Compliance for medical devices, pharmaceuticals and consumer products. His roles expand across Head of Quality Assurance, Global Quality Systems Director, Sr. Site Quality Assurance Manager, Plant Quality Assurance Manager, and Lead Faculty.
Aaron has taught over 800 FDA employees and 1,200 industry professionals 21 CFR 820 Medical Device Quality System Requirements (QSR) and ISO 13485 Quality Management Systems (QMS). He has also taught focused courses on MDSAP, Design Controls, CAPA, Purchasing Controls, Lead Auditor, and 510K DeNovo.
Aaron graduated from Purdue University with Bachelor of Science in Mathematics and Industry Management, and a Master of Science in Regulatory Affairs from Northeastern University. He has three ASQ certifications (Quality Engineer, Software Quality Engineer, and Six Sigma Blackbelt) and is an Exemplar certified lead auditor for ISO 9001 and 13485.
Elis Santos
Elis an experienced e-Learning Developer with the capacity to create complex interactions using Articulate Storyline and other development tools. Passionate about design, she always uses it to the learners' advantage, making the most of every element on the page.
She graduated with a bachelor's degree in Language, Culture and Communication from the University of Birmingham. Having worked as a Portuguese teacher for over ten years, she pivoted to a Learning Specialist role in 2020. Elis has since gained experience in a variety of sectors, from higher education to governmental, and now pharmaceutical.
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Katarina Ojala
Katarina is a Learning Experience Designer and Instructional Designer with over a decade of experience in the field of education. She has been involved in developing and piloting many innovative learning solutions both on-site and digitally.
Holding a Master's degree in Education, Katarina's career has encompassed a diverse array of roles, including consulting, training and research.
Holding a Master's degree in Education, Katarina's career has encompassed a diverse array of roles, including consulting, training and research.
Katarina’s areas of expertise include digital learning development, learning experience design, curriculum design, LMS/LXP and graphic design.
Dr Steve Curran
Dr Steve Curran is Senior QA/RA Expert at Meddev Solutions.
Steve holds a PhD in Clinical Engineering, and has worked as a research engineer, project manager and a regulatory and quality assurance professional. With an extensive background in manufacturing process engineering, medical device design and global regulatory and quality affairs for the medical device industry, he has significant experience managing projects from concept to completion as a senior leader.
His career has been truly global. Steve spent five years in managerial positions, before working as Lead Technical Auditor with a major Notified Body for eight years. More recently, he worked as Head of Regulatory & Quality Affairs at a medical device company, before ultimately spending three years as Compliance Director in the area of orthopaedics.
Steve brings a wealth of experience to this role, with significant involvement in auditing and compliance. He has also presented at a number of international conferences on biomaterials, tissue engineering and regenerative medicine and has published several peer reviewed papers in these areas.