ZiMedical

Regulatory Affairs Consultants for Medical Device and IVD Get a Free Consultation Today!

Services We Provide and Markets We Support

Medical Device Submission / Registration

Quality Management

U.S. FDA Agent

Other Services:

Compliance & Enforcement

Product Development

Local Agent Representation

Regulatory Information Technology Systems Selection & Implementation

Global Program and Project Management (Pharma and Device)

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Understanding regulatory systems in emerging markets goes beyond reading regulations, by doing, through each registration, each product testing, and each consultation with officials and reviewers. Take advantage of our experiences and gain your regulatory approval the RIGHT way.

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Latest posts in our blog

Clinical Trials Hit by Ransomware Attack

03/16/2022

According to the New York Times a recent incident was yet another reminder of the increasing risks to medical device and other healthcare companies.

Cybersecurity Alert: Vulnerabilities identified in medical device software components: PTC Axeda agent and Axeda Desktop Server

03/15/2022

The FDA is alerting medical device users and manufacturers about a cybersecurity vulnerability identified for the Axeda agent and Axeda Desktop Server. The agent and desktop server are used in numerous medical devices across several medical device manufacturers and all versions of Axeda agent and Axeda Desktop Server are affected. On March 8, 2022,...

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mingzi@zi-medical.com (mandarin speaker)

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