Who are we?
We are a team of experienced QA/RA professionals, working in the medical device industry for both manufacturers and notified bodies.
We routinely train and provide consultancy services to the top medical device manufacturers around the globe and have authored the highly rated ‘MDR Guidebook’ to assist 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