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 Medical Devices:
Rest of World regulatory and quality compliance expertise is provided by our parent company, Global Regulatory Services (GRS).
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
Steps in Launching a Medical Device in the USA: A 10-step guide
Is it really a 10 step process?
29.7.2024