Materials Used for Manufacturing Medical Devices: A Guide
When manufacturing medical devices, safety, regulatory compliance, performance, and resilience are the major factors to focus on. Furthermore, while choosing medical device manufacturing materials, biocompatibility, durability, and regulatory compliance are some of...
ISO 13485 Certification for Class A and B Medical Devices
In the medical device industry, safety and quality are non-negotiable. Hence, various regulatory guidelines govern the medical device industry to ensure high-quality, safe, and effective devices are being manufactured. One such guideline is ISO 13485 standards. ISO...
How to Identify a Predicate Device? A Detailed Guide
Planning to market your medical device in the US? Then, you will have to secure the US FDA 510(k) approval. For which you will require proper documentation and have to select the appropriate predicate device. You will need the predicate device to prove substantial...