Understanding Post-Market Surveillance:In the fast-paced world of medical technology, the journey of a medical device doesn’t end with regulatory approval. It ...

The FDA is making significant strides in integrating real-world data (RWD) into the regulatory framework for medical devices. A recent 40 page draft guidance, ...

FDA Quality Management System Regulation (QMSR)In February 2022, FDA released proposals for aligning their Quality System Regulation (QSR) with the commonly ...

The gender data gap of high-quality, gender-specific data represents a critical challenge in healthcare, particularly in the development and efficacy of ...

As major buyers continue to request Environmental, Social and Governance (ESG) reporting from suppliers, there will continue to be new and revised regulations ...

This year’s International Women’s day theme is ‘Inspire Inclusion’. In this blog I’ll share statistics around women in Science, Technology, Engineering and ...

This article highlights some of the similarities and differences between the Medical Device 510(k) and CE Marking regulatory pathways and helps harmonise some ...

Whatsapp Share Tweet Share Healthcare providers regularly ...

Whatsapp Share Tweet Share Single-use medical devices also referred ...

It’s job-hunting season! This blog shares favorite questions and techniques (with the reasoning behind these questions) that our employees have used or ...