GB 3232-1982
Abolished
T/CAMDI 026-2019
Active
Group standards
T/CAMDI 026-2019 Customized Medical Device Quality System Special Requirements Group Standard
T/CAMDI 026-2019 Customized Medical Device Quality System Special Requirements Group Standard
Price:
$ 20.00
Basic Information
Standard Code:
T/CAMDI 026-2019
Standard Type:
Group standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Generally, it refers to microsurgical instruments
ICS Name:
Integrated medical science and healthcare devices
Publish Date:
2019-06-28
Implement Date:
2019-07-20
Scope
Main technical content: The main technical content of this standard includes: 1. Organizations and personnel; 2. Plant and facilities; 3. Equipment; 4. Document management; 5. Design and development; 6. Procurement; 7. Production management; 8. Quality management; 9. Sales and after-sales service; 10. Non-conforming product control; 11. Adverse event monitoring, analysis, and improvement. Scope of application: Applicable to customized medical devices, including additively manufactured implantable medical devices and non-implantable medical devices. It covers the production management of customized medical devices in fields such as dentistry, orthopedics, rehabilitation, and materials, as well as special requirements for post-market traceability and group quality standards in quality management systems for customized medical devices.
Development Information
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