According to the New York Times a recent incident was yet another reminder of the increasing risks to medical device and other healthcare companies.
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Zi Medical provides services globally to medical device, IVD and pharma companies including: See our company overview.
- Pre-submission Consultations and Fillings
- International Regulatory Strategy for One or Multiple Markets or Products
- International Product Registration and License Renewal
- GMP/QSD Registrations
- Regulatory Management Development
- Quality Compliance
- Regulatory Staff Training
- Process Improvement, Six Sigma
- Regulatory Information Technology Strategy
Major Regions covered include:
US, EU, China, Taiwan, Hong Kong, Singapore, Japan, Korea, Malaysia, Philippines, Singapore, Indonesia, India, Thailand, Vietnam, New Zealand, Australia, Mexico, Argentina, Brazil.
Cybersecurity Alert: Vulnerabilities identified in medical device software components: PTC Axeda agent and Axeda Desktop Server
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,...
The Customer is a US based software company who recently involved in medical device industry to develop software for clinical study and patient enhanced experiences. They are seeking a quality and regulatory consultation support for FDA and CE compliance while they developing variety for software to be used either alone or in conjunction with other...