About the Regulatory Compliance Clinic
In collaboration with our consulting partner MT Promedt Consulting and supported by NUS Enterprise, we have organised the following event to reach out to every one of you:
Regulatory Compliance Clinic
An exclusive 1-to-1 session with Dr Michael Rinck (MD of MT Promedt Consulting GmbH), Jason Lim (CEO of Stendard) and your team
Date: 6th & 7th March 2017
Time: 1 hour per team (to be allocated after sign-up)
Venue: NUS Enterprise@Blk71 (71 Ayer Rajah Crescent, #02-01, Singapore 139951)
Who should sign up?
Medical device companies looking to achieve ISO 13485 certification or meet US FDA requirements,
- Looking to expand into larger markets like Europe (CE Marking) and the U.S.,
- Any medical device companies with regulatory issues and require advices from the industry experts,
- Any potential startups looking to dive into the medical device sector.
All of you are welcomed to sign up using the form below! Each team will be allocated one hour for an in-depth discussion with our panels, so the slots are limited. Do express your interest as soon as possible to avoid any disappointment!
About Dr Michael Rinck
Dr. Michael Rinck is the founder and managing director of MT Promedt Consulting, a German consulting company specialised in regulatory affairs, quality management systems, CE marking and international product registrations for medical devices, IVDs and combination products. He is a regulatory specialist with strong scientific background in microbiology possessing a Diploma and a Ph.D. in Microbiology from Technical University Berlin and a License in Pharmacy. He has conducted research in antimicrobial coating, biomaterials and sterilisation technologies and developed and implemented these into routine manufacturing processes. As an independent consultant with over 25 years of international experience, he was responsible in several positions for R&D, quality control, manufacturing and QA/RA for major health care companies.
About Mr Jason Lim
Mr Jason Lim is the CEO and co-founder of Stendard, a cloud based software that simplifies the process for medical device companies to fulfil international regulations, such as ISO 13485 and US FDA 21 CFR, before products are approved for commercialisation. Conventionally, such work is performed manually and is very time-consuming. Stendard is the first to help small businesses achieve compliance in a fast, convenient, scalable and affordable manner.