Understanding Device Classification and Predicate Device Searches in the US
Launching a medical device in the United States requires navigating a complex regulatory environment governed by the U.S. Food and Drug Administration
13.8.2024
Understanding Device Classification and Predicate Device Searches in the US
Launching a medical device in the United States requires navigating a complex regulatory environment governed by the U.S. Food and Drug Administration
13.8.2024
Sterilisation Validation Reports for Medical Devices
Sterilisation validation ensures that products are safe for patient use by eliminating all forms of microbial life.
9.8.2024
Steps in Launching a Medical Device in the USA: A 10-step guide
Is it really a 10 step process?
29.7.2024
Investigator’s Brochure (IB) for Medical Devices
Sponsors are encouraged to review the full details of the MDR and the ISO 14155:2020 standard when preparing the IB.
18.7.2024
Secrets of MedTech Supply Chain Compliance
Unlock the Secrets of MedTech Supply Chain Compliance: Download Our Exclusive White Paper!
26.6.2024
How to assign Master UDI-DIs to contact lenses: A new regulation update
The European Commission on 20 October 2023 published an amendment which introduces a new concept of Master UDI-DI for contact lenses.
26.3.2024
On 6th December 2023, the USFDA announced the voluntary use of eSTAR - Electronic Submission Template.
29.2.2024
eSTAR: A New Way to Submit 510(k) Submissions Electronically
If you are a medical device manufacturer who plans to submit a premarket notification (510(k)) to the FDA, you may want to know about eSTAR
21.2.2024
