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| Product Registration | |
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Effective Technical File, Design Dossier and 510(k)
construction can aid the regulatory approval process enormously
and significantly reduce time to market.
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Omsbar has extensive experience in preparing
and presenting submissions to the European Notified Bodies and the
FDA for many medical device types. We can advise on realistic and
practical ways of complying with the various requirements.
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Product Registrations typically require approval
of:
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 Design
process |
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Design
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| Verification
and Validation of performance (may include Clinical Trials) |
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Manufacturing
process |
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Samples
of the manufactured product |
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Post-marketing
phase processes |
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Omsbar can act as the authorised representative
for non-European companies wishing to CE Mark products and place
them on the European Economic Area market.
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Our experience in medical device design can aid companies concerned with: |
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| Essential Requirements compliance | |
| Labelling content | |
| Language requirements and symbols | |
| EMC compliance | |
| Sterilisation validation | |
| Test Requirements | |
| Clinical Evaluation | |
| Hazards and Risk Management | |