Are you an SME or Medtech Startup developing a new medical device? Have you ensured a US focus in your regulatory documentation, product design and reimbursement strategy? Now you have the chance to access US specialists that can provide you the best advice within legal, regulatory and clinical aspects for US market access.

Medtech Innovation hereby invites its members as well as non-members to a preliminary conference/workshop where four FDA and medical device specialists from Minneapolis will present their take on what is needed to succeed in gaining an FDA approval, conducting clinical trials and why Minneapolis is the hub to conduct this in.

The workshops will provide knowledge and tools to all participants, but is also an opportunity to apply for an extended program taking place in Minneapolis in connection with the Advamed conference in San Diego, where a customized program will help participants find their regulatory pathways, connect with corporates and engage with key specialists.

To apply for the extended program in Minneapolis (San Diego if Advamed attendance is relevant) e-mail Sofie Wandrup, swa@sciondtu.dk or Annette Rye Larsen anryl@dtu.dk.

Program

13.00 Welcome
13.05 Introduction to BSR program and Minneapolis deep dive opportunity
13.15 Key-note 1: Minnepolis Medtech scene, companies, network, FDA etc., Frank Jaskulke, Medical Alley Association
13.45 Key-note 2: Small companies and regulatory pathways, trends and news from FDA, Mary Beth Henderson, RCRI
13.45 Pause- Networking
14.00 Key-note 3: Understanding the healthcare marketplace in the US. Marcus Mianulli, Gnarus Medical Consulting
15.15 Networking and 1-1 meetings with key-notes

30. maj 2017 13.00-17.00

Scion DTU Lyngby
Auditoriet, Diplomvej 372
2800 Kgs. Lyngby

Bemærk, at adgang til auditoriet sker via trapper.

Arrangementet er gratis.