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).
Medical Device Manufacturers have a legal obligation to regularly maintain and perform risk management analyses.
A ‘Label’ is the identity of the product.
It allows the identification of specific devices on the market and facilitates their traceability.