As your company grows, business activities increase. Accordingly, the amount of documents that record these activities increase too. Good document practice is essential to manage this growth. Here are 7 important points to take note of and apply!
Many changes have been introduced with the new EU MDR and IVDR - from the appointment of a Person Responsible for Regulatory Compliance (PRRC), to preparation of new Technical Documentation, to specific Post Market Clinical Follow-up required, and more!
We are excited to arrange for you to meet with Mr. Jason Lim, CEO of Stendard and Mr. Clemens Mohr, Director of European Regulatory Affairs at MT Promedt Consulting GmbH (Germany) in person! With decades of experience between them in supporting clients to successfully placing their medical device in the EU market, they will be able to address your questions and concerns regarding the new EU MDR.