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Services that we provide

  • CE Certification according to the following.
  • MDD (93/42/EEC).
  • IVMDD (98/79/EEC).
  • EU MDR (2017/745).
  • EU IVDR (2017/746).
  • USFDA certification process.
  • Registration and Medical device listing.
  • Premarket Notification/ 510 (k) Submission for Class II Devices.
  • Premarket Approval for Class III Devices.
  • Indian MDR- Medical Device Rules, 2017.
  • Test License and Manufacturing License process.
  • Documents preparation according to Checklist.
  • ISO 13485:2016- Medical device Quality Management System.
  • Medical Device Single Audit Program (MDSAP).
  • NIOSH.
  • European representative Guidance and support.
  • Country registrations.
  • Trainings on CE certification, USFDA, Indian MDR, ISO 13485:2016, MDSAP.
  • Free Sales Certificates and Test licenses.
  • Audit support (IQA, MRM) and Annual Maintenance Contract.
  • Document templates sale for Technical Documentation, ISO 13485:2016.

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November 23rd, 2022

The routes to conformity

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Clinical Development Plan (CDP)

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October 3rd, 2022

Identification and Traceability in Medical Device Industry

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