From idea to Commercialisation!
Create a pathway to protect your innovation with complete compliance with regulatory requirements.
A well thought regulatory strategy enhances your production, business development and marketing plans.
Regulatory First Responders for your medical device.
We act as your EU AR / PRRC and represent your innovation to the European Commission!
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Planning to enter the EU/USA?
Not sure about market entry requirements?
Worried about MDR/USFDA requirements?
We are here for you!
We have a list of ongoing and routine services through which we help our clients with complete regulatory compliance.
Check our wide offerings for IVD:
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!