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Regulatory Progress Associates
can help you:
- Compile a medical device CE
Marking Technical File (or
Design Dossier for Class III)
with evidence of compliance to
the Medical Devices Directive
(or the IVD/AIMD Directives).
- Receive a medical device CE
Mark certificate from a Notified
Body if Class I with Measuring
or Sterile function, Class IIa,
IIb, or III.
- Find a European Authorized
Representative if you have no
physical location in Europe.
- CE Marking Technical File or
Design Dossier compilation and
review.
Verification of Essential
Requirements.
- Product classification and
identification of applicable
standards for medical devices.
- Implementation and
maintenance of ISO 13485 quality
systems.
- Product labelling and
packaging review.
- Risk assessment and
management (ISO 14971).
- Development of Vigilance and
Post Market Surveillance
including Vigilance Standard
Operating Procedures and
Processes.
Call us
or email us your questions. We'll
get back with a free estimate.
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