Navigating Regulatory Approval
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?
This webinar is ideal for life science and health technology companies and innovators:
- companies in the product development phase who are looking to launch new products or services in the UK, EU and international healthcare environments and
- innovators at concept stage seeking to understand the regulatory roadmap for their product or service in the UK, EU and US markets
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.
Dr Anne Blackwood, Chief Executive, Health Tech Enterprise
Anne has been actively involved in intellectual property management and commercialisation of life sciences technologies for over 25 years, the last 20 years’ of which have been in healthcare. An experienced leader with a proven track record in launching successful medtech ventures.
If you have any questions about our courses or if you’re interested in booking multiple individuals for a transformative learning experience, we’re here to assist you. Reach out to us at enquiries@healthtechenterprise.co.uk, and our dedicated team will provide you with the information you need.
NHS trusts that are proud members of Health Tech Enterprise enjoy the exclusive benefit of complimentary attendance to this event.
