To be, or not to be?
Identify the intended purpose of your innovation and define its uses. Our experts will check if your innovation is a Borderline Medical Device or just another non-medical product!
If your Innovation is a Medical Device, then we NEED to TALK!
A Regulatory strategy will create a pathway to protect your innovation with complete compliance with regulatory requirements.
Is your innovation a Medical Product in the EU/USA?
Are you sure?
Let our Experts confirm it for you!
Medical Regulations around the world have different interpretation for different medical products. Sometimes an algorithm could be considered as a Medical Device and at times a wearable device might be a wellness product!
Do not worry, Our experts are right here to bring a solution.
Rest of World regulatory and quality compliance expertise is provided by our parent company, Global Regulatory Services (GRS).
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