Offer

Medical Device:
My service in the field of medical products is independent of location and time, always tailored to the customer. JC always focuses on the needs of the customer.

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Assessment of the biocompatibility, as well as preparation of the responsible expert opinion

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Support of the different phases to determine biocompatibility (planning, reporting, testing)

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Audits of the implementing CRO's

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Transformation from MDD to MDR for medical devices

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Preparation, support and follow-up of possible audits by authorities

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Consultancy for

Narcotics und Lab Construction

Audits:

All audits worldwide, including India and China, are planned and carried out by JC. All necessary travel and necessary administrative activities (visa, contact with the auditee, accommodation and necessary transport) are carried out by JC in consultation with the client.

•  Planning of upcoming GMP audits
• Contacting the auditee and preparation of all necessary documents prior to the audit, preparation of the agenda
  
• Audit execution
• Preparation of a CAPA plan, report and follow-up
• Sale of existing reports in consultation with the report owner
• Remote Audit