From Obtaining a Class II Medical Device Marketing Authorization to QMS Implementation: Steps and Pitfalls in Launching a Class II Business

On the day the permit was issued, the atmosphere at the site came to a standstill.A few days after rejoicing that "we can now ...

QMS Construction Roadmap for Class III/IV Highly Controlled Medical Device Marketing Authorization Holders: An Overview from Obtaining Type 1 License to Do…

The day the license arrives, there is a sense of relief within the company.However, the real starting line is from that point ...
GlobalSpec

Chapter 4: Recommended QMS Documentation

In Part 1, our goal was to create an organizationwide, business-oriented QMS, in which the financial and quality objectives were transparent. The QMS was to be based on the canonical set of ISO 9000 ...
MD&M East

Lost in Translation: The Challenges of a QMS Audit

You've developed a great product and feel ready to jump into Japan's medical market. Not so fast. Before you can sell your medical device in Japan, you need to register it. One of the key requirements ...