Clinical data strategy
A clinical data strategy shows how the investigations support the claims with needed clinical evidence and that your resources are allocated and focused. A carefully planned strategy from product development to the post-market phase can bring your device to market faster and supports marketing efforts for commercialization and a successful launch.
Clinical evaluation SOP
After assessing your type of device and internal processes, we compose a Standard Operating Procedure (SOP) that is the best fit for your device and processes.
IVDR reality check: are we moving fast enough?
As of February 2025, approximately 1,500 IVDR certificates have been issued. That’s progress — but is it enough? With...
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. Organizations that...
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 Software marks a...
Strategic clarity: The new currency in life science
In an industry shaped by rapid regulatory changes and global competition, leading life science companies are rethinking...
The FDA’s new transparency policy (Part 3)
In the third part of our article series on the FDA’s new “radical transparency” initiative, we explore strategic...