Who are we?
We are a team of experienced UK based medical device consultants, working in the medical device industry for both manufacturers and notified bodies.
We routinely provide medical device training and consultancy services to the top medical device manufacturers around the globe and have authored the highly rated ‘MDR Guidebook’ to assist medical device manufacturers in complying with the EU MDR.
Our expert team has been widely recognised and voted the 'Best-In-Class' Medical Device Regulatory Consultancy company of 2020 by MedTech Outlook magazine.
With our experience training both notified bodies and competent authorities, we can ensure our consultancy delivers solutions that work first time, every time.
YEARS OF EXPERTISE
TRAINING COURSES DELIVERED
The Meddev Solutions MDR book is your 'go-to' reference and tool kit for ensuring MDR compliance.
This guidebook contains a number of useful tools and tables to guide you through the MDR, such as:
device classification and their differences from the MDD
QMS requirements and how they align with ISO 13485
technical documentation requirements
clinical data requirements, including a handy checklist
general safety and performance requirements tables
annex and article guide
This European In Vitro Diagnostic Device Regulation Guidebook, is a comprehensive reference resource for In Vitro Diagnostic Device manufacturers operating or selling devices in the EU.
It distils the IVDR into meaningful chapters with a host of tools that can be used to assist in complying with the requirements of the IVDR.
Paperback available September 1st 2020. E-book available now.
Join the waiting list today and be the first to know when the IVDR Guidebook is available for purchase.