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Standards and Compliance
ISO 13485
Information and resources on ISO 13485, the international standard for medical device quality management systems.
Risk Management
Resources on identifying, evaluating, and mitigating risks associated with medical devices.
CE Marking
Details on obtaining the CE mark, which indicates compliance with EU safety, health, and environmental requirements.
Clinical Evaluation
Information on conducting clinical evaluations and trials for medical devices.
Good Manufacturing Practices (GMP)
Guidelines and best practices for manufacturing processes to ensure product quality and safety.
Other Relevant Standards
A collection of additional standards relevant to medical device compliance and quality assurance.
Post-Market Surveillance
Guidelines on monitoring the safety and performance of medical devices after they have been released to the market.
Regulatory Pathways
Country-Specific Regulations
Detailed information on medical device regulations specific to different countries in Africa.
Step-by-Step Guides
Comprehensive guides on the regulatory process for medical devices, broken down into easy-to-follow steps.
Regulatory Updates
The latest news and changes in medical device regulations across Africa.
Application Processes
Instructions and requirements for submitting regulatory applications for medical devices.
Common Pitfalls
Common mistakes and challenges encountered during the regulatory process and how to avoid them.
Regulatory Bodies
Information on key regulatory authorities in different African countries and their roles.
News and Updates
Industry News
The latest developments and news in the medical device industry, both regionally and globally.
Press Releases
Official announcements and press releases from MedTechRegulations and other relevant organizations.
Regulatory Changes
Updates on new regulations, amendments, and policy changes affecting the medical device sector.
Blog
Post-Market Surveillance
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