The new article highlights the aspects related to the content of the clinical investigation report, discusses additional considerations associated with the transitional period, and...

The new article highlights the aspects related to the timelines associated with the clinical investigations, the way they should be calculated, and other relevant...

The article highlights the key points associated with the regulatory framework for specific categories of medicinal products. Table of content ...

Complaints handling mistakes, medical device reporting, and CAPA are the most common reasons for FDA 483 inspection observations, but why? Reasons for FDA 483s related...

The extension of MDR implementation timeline has now become reality. On March 20, 2023, the Regulation (EU) 2023/607, which amends the Medical Device Regulation...

The extension of MDR implementation timeline has now become reality. On March 20, 2023, the Regulation (EU) 2023/607, which amends the Medical Device Regulation...

A clinical investigation plan (CIP) is an essential part of any medical device clinical trial. The CIP is a standalone document that includes...

As we reach the second anniversary of the date of application of the EU’s MDR, it’s an excellent opportunity to reflect on the journey...

<!----> At least for those manufacturers that struggled for a long time printing Instructions for Use (IFU’s) without...

The article highlights the key points associated with the substantial changes to performance studies in the context of...

The article provides an overview of the revised guidance document addressing the classification rules. ...

The Council of the European Commission concluded in a meeting on December 9th to address member states’ concerns...