When: 4 June 2024
Where: TOPRA OFFICE, 3 Harbour Exchange, London, E14 9GE, United Kingdom
Time: 12:00 - 17:00
Navigating the regulatory landscape for medical device innovations and new products
Who Should Attend?
This session is relevant to anyone who is either navigating the medical device regulatory landscape for themselves or their organisation or guiding others. It will also be useful to those who want to prepare their organisation to establish regulatory approval within their product development programmes. The discussions will be relevant to medical devices as well as the expanding market of IVD, combination products and software as a medical device applications.
Individuals from organisations in any area of sector, whether they are general or more specialist, will be able to contribute to and benefit from the debate.
Areas of Discussion
The discussion will be as free flowing as possible around the following key discussion points:
- Challenges faced by innovators: steep learning curve and confronted with a range of topics such as IP, market dynamics, commercial strategy etc. regulation typically low on the agenda so how to use awareness of regulatory pathways to accelerate R&D and improve chance of market access. Improving access to funding through a knowledge of pathway, costs and indicative conformity assessment timelines.
- Finding the Right Guidance: How can I be sure I have the current information, advice and guidance for my idea or product? How can I be certain that I am using the most effective approval process?
- Getting the basics right. Intended purpose & functional characteristics drive qualification as a medical device/IVD and indicate risk classification and conformity assessment pathway.
- Planning for safety. Using essential principles to identify safety variables, identify standards, plan for testing and determine who to undertake testing and scheduling. Also, touch on cost of failing to consider safety adequately (patient harm, ~10% drop in share price for companies with Class 1 recall in US etc.).
- Impact of Product Development Pipeline: How do I plan for this in my development pipeline? How do I make sure I get the right approval outcome so that I can move to production as planned?
- Impact on Creativity and Innovation: How can I use the application process in a way which enables and embraces our creativity and innovation?
Speakers
 |
|
Michael Kipping MTOPRA, Director, Medical Technologies EMEAA for Element Materials Testing, TOPRA President
Michael is Director, Medical Technologies EMEAA for Element Materials Testing, which is a global testing, inspection, calibration and certification business. Previously, he worked for Innovate UK as a Health Innovation Lead managing a UK government grant funding programme (Biomedical Catalyst) that provided £30M per annum to support UK SMEs developing innovative health and life science products.
|
|
|
Sue Spencer, Head of In Vitro Diagnostics & Principal Consultant, Qserve Group
Sue leads Qserve’s IVD service, is EU Regulatory and Quality Expert including CDx and Lead Auditor. She has over 30 years’ of experience in the Medical Device and IVD industries including extensive notified body experience.
Sue is an experienced trainer on a variety of IVD topics and particularly enjoys creating workshops to improve hands on experience with the requirements.
|
|
|
|
Pricing
Standard
- Member: £285+VAT*
- Non-member: £365+VAT*