MedTech

It is common knowledge that supplier quality is a critical piece of any MedTech QMS. No matter which regulatory requirements apply to you, or which ISO standards you comply with, supplier quality plays a fundamental role in ensuring your product...

The new EU Medical Device Regulation is set to enter into force on May 26, 2021, which is less than a month away now. The Swiss Medtech is geared up with its transition plan in the event a mutual recognition...

Real World Evidence (RWE) is playing an increasingly significant role in the medical device industry. The FDA has recently pushed for an increase in using RWE to support regulatory submissions, in an effort to promote public health. To define what...