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CMI Certification Body for Certification Management System
As of July 1, 2024, the Certification Body for Certification of Management Systems (COSM CMI) has been established within the organizational structure of the Czech Metrology Institute (CMI).
COSM CMI has been accredited by the Czech Accreditation Institute (CIA), o.p.s., as an accredited body No. 3266, in key technical areas covering both non-active and active medical devices, their manufacture, sterilization, distribution, and maintenance (service).
Certification is provided for quality management systems for the provision of medical devices and related services (QMS-MD) according to the following standards ČSN EN ISO 13485 ed. 2:2016, ISO 13485:2016, EN ISO 13485:2016.
Download the Annex to the Accreditation Certificate here.
No. | Main Technical Areas | Specification of Standards |
1. | 1. Non-active medical devices | ČSN EN ISO 13485 ed. 2:2016 ISO 13485:2016 EN ISO 13485:2016 |
1.1. General non-active, non-implantable medical devices | ČSN EN ISO 13485 ed. 2:2016 ISO 13485:2016 EN ISO 13485 | |
1.2. Non-active implants | ČSN EN ISO 13485 ed. 2:2016 ISO 13485:2016 EN ISO 13485:2016 | |
2. | 2. Active (non-implantable) medical devices | ČSN EN ISO 13485 ed. 2:2016 ISO 13485:2016 EN ISO 13485:2016 |
2.1. General active medical devices | ČSN EN ISO 13485 ed. 2:2016 ISO 13485:2016 EN ISO 13485:2016 | |
3. | 5. Sterilization methods for medical devices | ČSN EN ISO 13485 ed. 2:2016 ISO 13485:2016 EN ISO 13485:2016 |
5.1. Sterilization using ethylene oxide gas (EOG) | ČSN EN ISO 13485 ed. 2:2016 ISO 13485:2016 EN ISO 13485:2016 | |
4. | 7. Parts and services | ČSN EN ISO 13485 ed. 2:2016 ISO 13485:2016 EN ISO 13485:2016 |
7.5. Distribution services | ČSN EN ISO 13485 ed. 2:2016 ISO 13485:2016 EN ISO 13485:2016 | |
7.6. Maintenance | ČSN EN ISO 13485 ed. 2:2016 ISO 13485:2016 EN ISO 13485:2016 |
Services offered by COSM CMI
COSM CMI provides certification or transfer of certification of quality management systems for medical devices to all economic operators and other interested parties.
Why certify with COSM CMI?
Credibility – Certification under COSM CMI guarantees high prestige and assurance that the quality management system meets national and European regulatory requirements as well as international harmonized standards.
Compliance with MDR – COSM CMI offers comprehensive support in linking ISO 13485 with MDR requirements, which is essential for placing safe and effective medical devices on the EU market.
Experience and expertise – Our experts, with many years of practice in quality management, metrology, and conformity assessment, ensure a professional approach and effective communication.
Efficient process – We provide either new certification or a smooth and rapid transfer to COSM CMI, without unnecessary delays and excessive administrative burden.
List of issued certificates:
| MANUFACTURE | CERTIFICATE NO. | DOWNLOAD |
L I N E T spol. s r.o ELLA-CS, s.r.o. | 0812-CC-00001-24/02/A/B/C 0812-CC-00002-24/02/A/B/C | Certificates available for download at COSM CMI. Certificates available for download at COSM CMI. |
Address
Vnitřní organizační jednotka
Head of Department
Mapa
Další služby
Inquiries and Applications
All inquiries regarding the certification of management systems should be directed to: COSM@cmi.cz
Guidelines for submitting an application for certification of management systems in accordance with ČSN EN ISO 13485:2016 ed. 2 – Medical devices – Quality management systems – Requirements for regulatory purposes can be found here.
The necessary application forms are available here.
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