Obelis European Authorized Representative Center
"CE Marking Consultants with a Reputation for Excellence"
Obelis News:
Miguel Ohn
With 13 years of experience in European Authorized Representative services and EU Regulatory Affairs for medical devices, in-vitro medical devices and overall EU New Approach directives, Miguel Ohn has been advising non-EU and EU manufacturers regarding a number of different regulatory matters.
Mr. Ohn has experience in regulatory affairs such as the following:
- Borderline classification issues
- Vigilance and traceability procedures and vigilance case handling
- Labeling compliance
- Regulatory guidance of EU distributors in coordination with the manufacturer.
- Overall regulatory guidance on day to day compliance in the EU market
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