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).
AI is transforming the healthcare sector in many ways, from improving diagnosis and treatment to providing personalised care and support.
The EU MDR extension for certain medical devices only allows you up until 31st December 2027 or 2028 if you have a signed contract..
Prioritise patient safety with these steps!