Course overview

Medical Device Single Audit Program (MDSAP)

The Medical Device Single Audit Program (MDSAP) is intended to allow MDSAP-recognised Auditing Organisations to conduct a single audit of a medical device manufacturer that will satisfy the relevant requirements of the medical device regulator authorities participating in the program.
Our 1.5-day in-depth training course has been created for Medical Device Clients selling into multiple jurisdictions, and specifically into Canada. This is not just a simple read-and-understand MDSAP course. This is a hands-on 'how-to' guide which you can actually use immediately to get you through the MDSAP audit process.
Gain the knowledge and skills you require to successfully host a MDSAP audit within your organisation.
Format 

Virtual
Instructor-Led

Date / Time

Select your date below

Price

€1,100

Duration

16 Hours

Time

1pm - 5pm

Time Zone

GMT

Course Information

Dates & Prices
Course Syllabus 
What's Included
Technology Requirements
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Training Dates

We're currently finalising our 2024 course calendar. Register your interest below to be the first to receive new dates! 

Training Times

1 pm - 5 pm GMT 
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Discounts 

Group booking discounts are available as followed:

• 3 – 5 attendees receive 15% discount
• 6 or more attendees receive 20% discount

Email our team at [email protected] and one of the team will provide you with your unique discount code or invoice. 

More than 8 attendees?

If there are more than 8 people from your organization that would like to take this course, consider arranging an in-house training. The price can often work out cheaper, and the course can be customized to your exact needs.

What Is Included?

▪    Direct, live access to an expert trainer
▪    Access to the Meddev Solutions Training Portal
▪    Fully Interactive Course - Polls, quizzes and breakout sessions 
▪    Downloadable Resources 
▪    CoE Accredited Certificate of Completion
▪    Knowledge Checks
▪    Full Tutor Support 

Course Agenda


Day 1:
  • Principles of MDSAP
  • - What is MDSAP and what are the benefits?
  • - QMS basis – relationship with 13485
  • - Countries – members, observers and affiliates
  • - What does the future of MDSAP look like?
  • Overview of AOs and their responsibilities
  • - What is an AO
  • - Who are the AOs
  • - What are their responsibilities


Day 2:

  • The audit process
  • - Audit structure
  • - Audit sequence
  • - Audit cycle
  • - Audit types
  • - MDSAP Chapters

Learning Objectives

  • Gain a solid understanding of what the MDSAP means
  • Understand how the MDSAP audit process works
  • Gain effective tools and techniques on how to prepare
  • Understand how the MDSAP differs and fits with other certifications
  • Understand what auditing organisations are looking for
  • Understand MDSAP non-conformities and their impact

Who Should Attend? 

This MDSAP auditor training course has excellent value for anyone involved in implementing or maintaining a QMS.

  • ​Quality Assurance professionals
  • Quality Engineers
  • Research and Design Engineers
  • Internal Auditors
  • Quality Managers
  • Manufacturing Engineers
  • Regulatory professionals

Technology Requirements

Operating system
Windows requirements: Windows 7 or later
Mac requirements: Mac OS X Yosemite 10.10 or later
Linux requirements: 64-bit, Ubuntu 14.04+, Debian 8+,openSUSE 13.3+ or Fedora Linux 24+

Processor
Windows requirements: Intel Pentium 4 or later
Mac requirements: Intel
Linux requirements: Intel Pentium 4 or later

Internet connection
Required

Zoom

We use Zoom for our virtual classes. You can test your connectivity and ability to use Zoom at zoom.us/test.

Get your training agenda

Simply fill in the form to access your training agenda now.

Don't just take our word for it

Witness it first hand, directly from our previous attendees 
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"Thanks a million, the course was excellent and very enjoyable!"

Carolyn B

GS Medical
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Meet your instructor

Colm O'Rourke

Trainer & Consultant

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.
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.
Rod Beuzeval

Training for your team,
your way

We understand that every company is different and face unique challenges everyday. At Meddev, we can tailor any of our courses around your organisation’s specific needs and products. 

Bespoke learning experience

Develop your course with a leading subject matter expert to meet the specific needs of your organisation

Maximise your budget

Cut unnecessary costs and allocate your budget on what matters most

Track employee progress

Keep track of your employees’ progression in your own workspace

Get your training agenda

Frequently asked questions

When will I receive the course confirmation details? 

Once your booking has been placed and confirmed, you will receive an email which contains your account login details. You can access your payment receipts, course details, learning materials and more in your account! 

What is included in the course?

▪ Direct, live access to an expert trainer
▪ Access to the Meddev Solutions Training Portal
▪ Fully Interactive Course - Polls, quizzes and breakout sessions
▪ Downloadable Resources
▪ CoE Accredited Certificate of Completion
▪ Knowledge Checks
▪ Full Tutor Support 

Is this course live?

Yes! This course is completely live with a Centre of Excellence approved industry-expert. You can ask questions throughout the course as if you were in a real classroom. 

What time is this course?

We run this course from 1 pm - 5 pm GMT. If you can't make the live sessions, don't worry. We will record them, so you can catch up on anything you've missed!

Do I get a course certificate?

On successful completion of the course, you will receive a certificate of completion that can be used to demonstrate your knowledge to your employers and Notified Bodies. 

What payment methods do you accept?

The fastest and easiest way to pay would be to use your company credit card. If you cannot do that, and you require a PO, please email our team at [email protected]

Do you offer group booking discounts?

Absolutely! 3 – 5 attendees receive a 15% discount and 6 or more attendees receive a 20% discount. If there are more than 8 people from your organization that would like to take this course, consider arranging an in-house training. The price can often work out cheaper, and the course can be customized to your exact needs.

Can I transfer my place to another colleague?

Yes of course. If you can no longer attend the course, you can transfer your place at no additional cost.

What application do you use for the training?

We use Zoom for our virtual classes. You can test your connectivity and ability to use Zoom at zoom.us/test.
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