Mon
Jun, 23 2025
Why FMEA Differs from ISO 14971 in Medical Device Risk Management
Every medical device product (or process used to make medical devices) carries the risk of...
Fri
Jun, 20 2025
Understanding Pre-determined Change Control Plan (PCCP) for AI/ML Medical Devices
Medical devices in themselves are a marvel of modern science. However, as our technologies become...
Wed
Jun, 18 2025
Top 10 Medical Device Companies in the World
The medical device industry is one of the most dynamic and strategic in the entire...
Mon
May, 19 2025
Quality Control in Medical Device Manufacturing
In the highly regulated world of medical devices, the concept of quality is a must....
Fri
May, 16 2025
Different 510(k) Routes for FDA Approval – Special, Abbreviated & Traditional
The US FDA remains ever vigilant about the products entering the US medical device market....
Tue
May, 13 2025
Intended Use & Indication of Use – Implications for Drafting a Technical File
The medical device regulatory sector incorporates a multitude of terms which may sound confusing. However,...
Tue
Apr, 22 2025
Co-existence of dFMEA and ISO 14971
Design FMEA (Failure Mode and Effects Analysis) and ISO 14971 are the most sought-after risk...
Thu
Apr, 17 2025
Compliance with Electronic Signatures 21 CFR Part 11
Electronic signatures are not a new concept, especially in today’s increasingly digital world. In the...
Mon
Apr, 14 2025
How to Identify a Predicate Device for 510(k) Notification
A predicate device is defined as a medical device previously approved by the US Food...
Fri
Feb, 21 2025
Essentials of Electronic Clinical Data Capture
Clinical trials and research face many challenges, such as regulatory requirements, patient recruitment, financial management,...
Wed
Feb, 19 2025
Registering Your Medical Device in the Kingdom of Saudi Arabia
As the Kingdom of Saudi Arabia (KSA) has opened its doors to the world, many...
Thu
Jan, 23 2025
Elements of Device Master Record (DMR)
The Device Master Record (DMR) is a regulatory requirement established by the Food and Drug...
