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!
Click Here to Read More:
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).
Audits are a key component of ISO 13485:2016
What are EU Reference Laboratories under IVDR? EURLs
ISO 13485:2016 – your partial gateway towards market entry around the World!