Fast track for mononational clinical trial applications in Sweden
Starting September 1, 2025, the Swedish Medical Products Agency (Läkemedelsverket) introduced a...
Category: Article
IVDR reality check: are we moving fast enough?
As of February 2025, approximately 1,500 IVDR certificates have been issued. That’s progress — but...
Could your overly burdensome QMS be the organization's own doing?
Although the above statement is intentionally somewhat provocative, it does hold a degree of truth....
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...
Strategic clarity: The new currency in life science
In an industry shaped by rapid regulatory changes and global competition, leading life science...
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 (Part 2)
In the second part of our article series on the FDA’s new “radical transparency” initiative, we...
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...