Belsyme Regulatory Consulting

Belsyme Regulatory Consulting is a principal-led boutique practice established by Sonja Cuce in Melbourne. It advises pharmaceutical and medical-device businesses on Australian regulatory strategy, product registration and lifecycle management. Its device work focuses on planning TGA submissions and using evidence from comparable overseas regulators, alongside ongoing variation, transfer and compliance support.

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Kiwa Dare

2 reviews · updated over 2 years ago

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Medizinprodukteberater Course: Requirements, Tasks, Responsibilities

Dr. Oliver Eidel

30 views · 7 months ago

Best team setup for Class I (EU) medical device QMS and technical documentation?

Anonymous · 1 comment

8 months ago

We are a small team preparing to set up our Quality Management System (QMS) and Technical Documentation for a Class I medical device in the EU, which includes a hardware component. We are considering

Accepted 1 answer

If the founders don't have much experience with QMS or regulatory compliance for medical devices, it's really important to build internal expertise in