Technical documentation
All documentation are baced on Recommendation NB-MED/2.5.1/Rec5 “Technical Documentation” as well as in MedDev guidelines (eg MEDDEV 2.7/1 rev.4 “Clinical evaluation: a guide for manufacturers and notified bodies”).
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I provide consulting on national requirements and certification roadmap, submission of documents and follow-up during the assessment process, communication with the certification body on behalf of the manufacturer.
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Consultancy
Consultations on any issues related to medical devices: production, quality system implementation, conformity assessment and others.
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