Celebrating Three Decades of Excellence: Platform94’s Inspiring Journey from GTC
As Platform94 celebrates an impressive 30 years of service, we are honoured to reflect on their remarkable transformation.
18.11.2024
Internationalising MedTech Innovation
Don’t miss this chance to gain critical insights from industry experts with decades of experience navigating the complexities of MedTech international
11.11.2024
Understanding the Certificate of Free Sale in the EU: A Comprehensive Guide
A Certificate of Free Sale (CFS) is an essential document for manufacturers & authorised representatives looking to export medical devices outside EU
23.10.2024
Here’s a breakdown of the certificates from each region and factors to consider for the first market entry.
2.10.2024
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
