Medical Device 510(k) Clearance - Cyber Security
Zener Engineering Services Ltd • 13 June 2019
A Medical Device manufacturer required support with an FDA 510(k) Clearance for a new medical device utilising artificial intelligence.
To read the full article clickhere.
Life Science organisations run the risk of costly project mishaps. They agonise over the causes of project disappointments and try to recover floundering projects.
ZES are proud to announce their new Cyber Security Services. Discover how these services can protect individuals or your small business from evolving digital threats
A 'well-established' cleanroom supplier proposed cleanroom fans unsuitable for a new sterile manufacturing facility, required by a Cell and Gene Therapy Client
Life Science Suppliers - Are You Ready To Cut Corners? The potential for catastrophic consequences and harm to Patients is real! You will be held accountable.
When Streamlining Validation Approaches in Life Sciences Becomes a Token Gesture. Has Blue Sky Thinking gone too far? A troubling trend emerged in Life Sciences?
The correct approach to an FDA Inspection is vital for the long-term success of any Life Science Organisation. A poor regulatory inspection is very expensive
In the intricate and ever-evolving world of Life Sciences, the importance of Data Integrity cannot be overstated. Zener Engineering Services Ltd are experts.
Discover how validation in the Life Science Industry is evolving beyond compliance into a value-driven, visionary approach. Is this moving forwards or backwards?
Easter Message from Zener Engineering Services Ltd 2025, starring Shadow and Misty-Blue. Happy Easter to one and all. They say never work with Easter Bunnies!
Why Senior Management Ask For Help - And then don't listen to the advice provided! The reasons can be numerous and complex, but may never be what they seem.
