Knowledge center

Home
Knowledge center

Show: All / Whitepapers / Webinars / Articles / Flyers / Blogs / Podcasts / Documents

Category:

Show content from:

Date

Search

Highlights

Qserve supports you in supporting the Ukraine

Our feelings, prayers and our support are for all Ukrainians who are fighting for their right to exist.

Medical Devices Ukraine Highlights

FDA's proposal of a revised 21 CFR part 820 to align with ISO 13485:2016

On the 23rd of February 2022, the FDA published their proposal for a revised 21 CFR Part 820, Quality System Regulation.

FDA ISO 13485:2016 Highlights

Results

Wake up to the IVDR! Today, the 26th of May, is the 'Date of Application', the date the new IVDR goes live

Wake up to the IVDR! Today, the 26th of May is the “Date of Application”, the date the new IVDR goes live. Many describe this as a cultural shift as it does not just change the regulation but in many cases the way we do business. It will impact all IVDs on the EU market and the associated supply chain.

Europe In-Vitro Diagnostics IVDR MDCG Services

Wouter Mattheussens joins Qserve

Wouter Mattheussens has joined Qserve Group where he is part of the Qserve CRO team and works as a Clinical Project Manager.

CRO GCP ISO 14155

Saskia Schoenmakers joins Qserve

Saskia Schoenmakers has joined Qserve Group as a consultant where she is part of the IVD team. With her experience in IVD product development, technical documentation and technical & application support, she will make a valuable contribution to our global customers.

FDA In-Vitro Diagnostics ISO 13485:2016 IVDR Technical Documentation

It’s a small world after all… but with big differences in regulation

Nearly every jurisdiction around the world has a formalized registration process that medical device manufacturers must follow to legally sell a product into markets. Let’s have a look at the mid-size European medical device manufacturer.

MDSAP Medical Device Regulations

MDCG 2022-5 and the concept of “liable to act on the body” - Much ado about nothing?

The guidance on the borderline between medical devices and medicinal products is now released in its final version. Its publication is very welcome as it replaces the old “borderline manual”, formally only applicable to MDD but practically, lacking alternatives, still used to unravel complex MDR classification issues.

MDCG Medical Device Regulations

1 2 3 4 5 ... Next

How can we help you? Contact us