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The medical device design and development process is a complex and interconnected series of steps. It is a long way down the road since CE marking. Each step has to be planned and executed carefully, in collaboration with various stakeholders. To complete the different stages of the Regulatory Process for MD and Product Development Process is always scattered with pitfalls which impair the product market release.
In this TRL Booster MedTech Edition (TRL-B ME) we examine ten main phases of a medical device product lifecycle which are essential in getting your product to the market quickly and efficiently.
TRL-B ME is wishing to give yourself the best chances for implementing your product with less delay, diligent work, better prepared dossier and an adequate structure to be launched into the market.
What we offer?
- Ten Workshops (WS) which address the “Technical Maturity Level” topics (TRL) enabling your product to reach CE marking under the best possible conditions.
- Following all WS (or only some of them: “A la carte” program) you will offer your target client the best product earlier.
- Several experts in TRL topics will accompany in each step you take. The general framework will be addressed during the first half a day, in which pivotal issues will be covered. The second half a day will be focused on your own product matters development.
- TRL-B ME offer an exclusive access to expert knowledge and valuable resources which enable to make the process smooth and hassle free.
- The last WS (WS11) opens up business and partnership opportunities with some of the main active countries in MedTech.
Our key differentiation points!
- TRL Booster MedTech Edition 2022 (TRL-B ME) is neither an accelerator program to prepare your company to pitch for money or contest, nor a training to improve your business model.
- Field experts will help you to identify, determine and solve issues in your own development product.
- TRL-B ME will not discuss neither general product development, nor all-purpose model but your own development risks within our company.
- TRL-B ME will go deeply in the agenda topics to understand stumbling blocks, challenges and critical aspects of MD process.
- TRL-B ME will enable you to meet Belgian and European Notified Bodies, as well as the AFMPS representatives, in such a way that you can prepare yourself to take with authorities in an efficient way (WS9).
- TRL-B ME will give an introduction to foreseen you company at international level as far as certification barriers are concerned (WS10)
- TRL-B ME will introduce you in MedTech ecosystem of France, Germany and Switzerland as well (WS11).
Whom is concerned?
- A team aiming to accelerate his MD product development or,
- A production unit that wants to anticipate problems,
- Already established company,
- Currently involved in MD product development (safe IVD),
- Above TRL3 / CRL3,
- Open to WSL’ s members and non-member.
Expected improvements?
- You will reach the CE marking with less trouble in order to jump from a Commercial Maturity Level 4 (CRL4) to a CRL6 with more confidence.
- ISO certification and CE marking are not only the "holy grail" for product commercialization. They increase the value of your company and establish good practices to produce and release high level of safety medical product.
- Actually, a medical device needs a long development process (TRL2 up to TRL8) before arriving in the market, which in turn implies the CE marking (TRL8). That is the only way to access customers (CRL6) and collect the first revenues.
RATE
Registration deadline for the full program by April 15th.
Prices are VAT excluded
Full program (WS1 up to WS11)
- WSL' s Member : 2400€
- Non-member : 3600€
Single workshop
Registration 10 days before the date of the WS (see agenda)
- WSL' s Member : 350€/WS first attendee – 220€/WS second attendee of the same company.
- Non-member : 410€/WS first attendee – 260€/WS second attendee of the same company.
NB1: The price includes catering, rooms, course notes, individual expert session
NB2: Registration is assured only upon receipt of registration fees. Fees are non-refundable in case of absence of the company representative(s).
CAUTION
During this first TRL booster MedTech edition we will be focused only on device related to MDR 2017/745 EU. IVDR will be treated during another edition.
Need more information?
Get in touch with u
Fabrizio Giannotta
f.giannotta@wsl.be