We make medical devices compliant and safer.

Need regulatory compliance for your device?

Understanding regulations is not easy but we make it easier with our industry-leading highly experienced experts,

From pre-market planning and product development to market approval and post-market surveillance, Whether you need help with preparing and submitting regulatory submissions, navigating the FDA and CE marking certification process, or ensuring compliance with medical equipment standards i.e IEC 60601, We get the job done.

Contact us.

The Process

  • Step 1- Evaluate

    Evaluate the device against the requirements of applicable standards.

  • Step 2- Documentation

    Assess documentation to determine compliance with applicable standards.

  • Step 3- Testing

    Conduct necessary testing to determine compliance with applicable standards.

  • Step 4- Assessment

    Conduct necessary third-party assessments to get your product ready for sale in the market.

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All about IEC 60601

as more and more manufacturers enter the market, there is a strong need to understand the rather complex safety compliance standard IEC 60601.

What Our Clients Say

  • "The team made sure they were with us throughout the regulatory process"

    Paras Sareen, Paras Surgico

  • "we got our device certified with ease"

    Kuldeep Singh, Allengers Medical Systems Limited

  • "all our queries about IEC 60601 resolved"

    Rammohan Singh, Conformity Testing Labs