Medical Devices

The most important element of getting your medical device approved is the implementation of a fundamental regulatory strategy and sound technical documentation.

Whether you have an existing device, an improved model, or a brand-new idea, RAAJ has all the knowledge and regulatory experience that you will need, to face the challenges involved in placing your medical devices on the market and keeping them compliant. You can leverage our expertise, taking the pain of regulation out of your business and speeding up the process. We have been supporting medical device companies for many years, in multiple markets. Our team can help you navigate all areas of quality assurance and regulatory affairs.

Our regulatory team provides you guidance and support to comply with the correct medical device regulation and market access requirements with a tailor-made service package we can provide excellent and efficient support in preparing access to global markets.

  • ISO 13485:2016 Certification
  • ISO 9001:2015 Certification
  • MDD to MDR Implementation as per Indian MDR-17 & EU-MDR
  • Medical Device Registration in USA, Europe, (EUDAMED), Singapore, Brazil, Canada, India and rest of the world (ROW)
  • Regulatory Filing to USFDA like 510(k)
  • US agent and e-filing Support
  • CE marks, UKCA marks and All EU Registrations.
  • Conformity Assessment.
  • Getting ISI marks as per BIS (Bureau of INDIAN STANDARDS)
  • Sugam Portal submissions from CDSCO/DCGI.
  • Preparation of Device Master File/technical documentation/Plant Master File.
  • Software verification and validation as per CSV, 21CDR Parts
  • Biocompatibility, Risk Management ISO 14971
  • Clinical Evaluation, investigation
  • Animal Study, Stability Data, Clinical Evidence
  • Post marketing surveillance, PMCF, Amendments, Supplements
  • Other ROW Country Specific Submissions
  • Lead Audits as per ISO 13485:2016, ISO 9001:2015, GMP and Compliance
  • Implementation and Training in MDSAP and MDR.
  • Online or In-House Training for Employee
  • Medical Device Manufacturing License for Indian Manufacturer (MD Form6)
  • PMA Submission
  • Investigational Device Exemption (IDE)
  • Emergency Use Authorization (EUA)
  • Review of marketing and advertising materials, publications.
  • Device and Plant Master File Preparation and Maintenance
  • Global Medical Device Approval and Registration
  • Design Control Documentation and Design History File (DHF)
  • Sterilization Method Validation and Documentation as per ISO 11135, ISO 11137, ISO 17665 requirements
  • Clean Room Validation Documentation and Methods as per ISO 14644 series of Standards
  • Medical Device Packaging Validation Documentation Requirements and Method of Validation as per ISO 11607-1 and ISO 11607-2 requirements
  • Medical Device Post Market Surveillance and Vigilance Requirements
  • Post marketing surveillance, PMCF, Amendments, Supplements