FDA’s new guidance: Computer Software Assurance (CSA) for production and quality system software
FDA’s final guidance on Computer Software Assurance (CSA) for Production and Quality System ...
Category: Medical devices (3)
The FDA’s new transparency policy (Part 3)
As transparency and consistency become increasingly emphasized by the FDA, medical device ...
The FDA’s new transparency policy
In a significant policy shift, the FDA has begun publishing Complete Response Letters (CRLs) for ...
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, ...