The FDA’s new transparency policy
In a significant policy shift, the FDA has begun publishing Complete Response Letters (CRLs) for ...
Author Aurevia:
Aurevia Announces Strategic Split into Two Independent Entities: Aurevia and Labquality
Aurevia announces a strategic restructuring that will result in the formation of two independent ...
New version of ISO 10993-1 - the core standard for the biological evaluation of medical devices
ISO 10993-1, the core standard for the biological evaluation of medical devices, has been under ...
PMS, Vigilance and Risk Management
Post-Market Surveillance (PMS) is more than complaint handling – it’s a strategic tool for patient ...
The importance of a robust Design and Development (D&D) process in medical device companies
In the competitive and highly regulated world of medical technology, a robust and well-structured ...
Tough times require sharp strategies – and the right expertise
The industry's financing climate has slowed down considerably. Investments in the development of ...
On-demand ICH GCP E6 (R3) training course
The International Council for Harmonisation (ICH) adopted the final version of Good Clinical ...
Does the Health Technology Assessment Regulation (HTAR) include medical devices?
The Health Technology Assessment Regulation (HTAR), officially known as Regulation (EU) 2021/2282, ...
Regulatory strategy vs. regulatory intelligence
Navigating the regulatory landscape of the medical device sector is a complex task, requiring both ...