Medical Device Services

Launching a Medical Device in European Market can be a hectic and time consuming process, even when you are familiar with most of the regulatory requirements. The mandatory change from EU Medical Device Directive to EU Medical Device Regulation from May 2020 onwards, it is going to be more challenging for manufacturers to get approvals.

GLOVERK is well equipped with the expertise required to fulfil the regulatory needs of Medical Device manufacturers across the Europe and USA. Our team consist of Doctors, Project Man- agers, Technical experts, Regulatory Affairs Specialist and Pharmacists with minimum of 5 years of extensive experience in Medical Device Industry. With an extensive experience and knowledge, we bring clarity, direction and speed to your business. We are here to save your Energy, Money and most importantly, TIME.

Services

  1. – Medical Writing

  2. – Clinical Evaluation Report writing (CER)

  3. – ISO 13485: 2016 Documentation

  4. – CE Marking

  5. – 510k Submissions

  6. – Predicate Device Search and Comparison – Drafting IFUs

  7. – Label Review

  8. – Technical File Preparation

  9. – Preparing SOPs

  10. – CAPA

  11. – Clinical Literature Review

  12. – Post market surveillance reports (PMS)

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