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).
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.