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NovaReg Regulatory Consulting

IVDR FDA

NovaReg Regulatory Consulting is based in New South Wales, Australia. It provides strategic and hands-on support for diagnostics and medical devices, including FDA 510(k) planning, IVDR pathways and quality systems aligned with ISO 13485 and MDSAP. The consultancy also works on design controls, risk management, performance documentation, CAPA and audit readiness.

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Can anyone recommend a consultant with experience writing a CIP for a Class IIb device?

Anonymous
8 months ago
Could anyone refer any freelance consultants in this community that have experience writing a Clinical Investigation Plan (CIP) for a Class IIb medical device? I might have an interesting opportunity
No answers yet
Medizinprodukteberater Course: Requirements, Tasks, Responsibilities 10:40

Medizinprodukteberater Course: Requirements, Tasks, Responsibilities

Dr. Oliver Eidel

30 views · 7 months ago
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DNV Product Assurance

updated about 2 years ago