Understanding the roadmap to regulatory approval in different markets is an essential part of any business plan for a new medical technology. Developing the right regulatory strategy enables you to get your products to market quickly by achieving compliance with UK, EU and international standards. This course will equip you with a “how to” guide and covers all essential information you need to plan for your regulatory approval process.
COURSE OVERVIEW
This course will be delivered online and explore key regulatory question, such as:
- What is a Medical Device?
- What class is my device?
- How do I get a UKCA mark & CE mark?
What is the difference? - What is the process?
- Who is involved?
- What evidence/documentation is needed?
- What is included in a Technical File
- Is the FDA approval process similar?
WHO WOULD BENEFIT FROM ATTENDING?
Anyone who is involved in developing new healthcare technologies and products, be it as an entrepreneur, clinician, academic, funder or commissioner, including professionals with an interest in/working in:
- Sales and marketing
- Business development
- Product development
- Research & development
- Technology transfer
MEET THE SPEAKERS
Chris Warwick, Senior Consultant. Health Tech Enterprise
Chris’ experience includes developing a prototype sensor for use by the water industry where he conducted research and explored methods to help overcome market entry barriers. He also has nearly twenty years’ commercial experience in customer facing roles, including ten years in a consultative account management role for a high tech IT company.
Mr Joop Tanis, Director of MedTech Consulting, Health Tech Enterprise
Joop’s career has spanned clinical, managerial, social investment and consulting roles through which he has developed an in depth understanding of the interplay between clinical care, innovation and entrepreneurship.
