About Regulatory1 in T2, rmv, Bangalore

We are expertise in Regulatory Affairs, providing testing solutions, audit to make the company in compliance with international standard and training.
•More than a decade years of experience in medical industry.
•Professional training program.
•Meets comprehensive ISO 10993 bio-compatibility requirements.
•World class technical expertise to deliver customizes solutions related to medical device industry.

Services offered

•CE marking, EU directives and guidance documents
•Risk management, analysis for medical device ; complance with ISO 14971
•Performance evaluation support for IVD.
•ISO 13485 certification, documentation and audit support.
•510(K), 21 CFR 820 audit support
•Biological safety evaluation for medical device.

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