How we can help

If you’re a small or medium size medical devices business (or startup), and you have a:
1.new prototype but are not sure about the regulatory requirements that apply to your product.

Abmed can help define a regulatory pathway for your products and provide ongoing advice as it’s developed.

2.completed product, but no Quality Management System (QMS).
Abmed can design and implement a QMS around your product, and support collection of the missing validation evidence and regulatory certification.

3.medical device and a QMS and are ready to apply for market access.
Abmed can help you prepare your submissions, interact with the regulator’s experts, and manage the process.

4.medical device on the market that is under investigation by a regulator.
Abmed can help you interact with the regulator, generate the required evidence and revise your documents and QMS to meet regulatory requirements.

How we can help

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400-0569-812

资料库

400-0569-812