Preparation of a regulatory dossier for the authorities can be cumbersome as It may contain tens of different documents, templates, reports, charts and graphics. When preparing a dossier for submission, the regulatory affair professional must present knowledge in technology, biology, microbiology, medical practice, safety regulations and engineering (validation and verification processes). Many of the documents in the dossier need to demonstrate and incorporate both scientific facts and data from clinical research and studies. These files must be prepared properly with the conformity route designated for the risk level of the device.

A team of professional medical device regulatory and quality experts are here to assist you with writing, reviewing or editing of an "Essential Requirements" table, a complete CE technical file, a traditional 510k or a complicated PMA file. We can prepare and finalize the legal regulatory documents with your designated local representative or an OEM from which you wish to source a private labeled device.  We would be happy to share our extensive experience and accomplishments in thousands of global regulatory submissions to contribute to your business success.

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