New Opportunities in the Medical Devices Manufacturing Segment

by Sudhriti M | Oct 30, 2024 | Medical Device

The Indian medical device industry is witnessing a double-digit growth rate. It is one of the top 20 markets in the world and the 4th largest in Asia. Moreover, the Indian medical device market size is approximately $ 11 bn. Infrastructural upgrades and increasing...

Materials Used for Manufacturing Medical Devices: A Guide

by Sudhriti M | Oct 30, 2024 | Medical Device

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

by Sudhriti M | Oct 30, 2024 | Medical Device

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

by Sudhriti M | Oct 30, 2024 | Medical Device, Medical Device License Requirements

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...

US FDA 510(k) Dossier Preparation: Everything You Need to Know

by Sudhriti M | Oct 30, 2024 | Medical Device

510(k) submission is a specific type of regulatory premarket submission made to the Food and Drug Administration (FDA) for Class I, II, and III medical devices. This premarket submission is used to demonstrate evidence of substantial equivalence. The process is...