ISO 13485.
Certify your quality management system through KEMA
ISO 13485 is the internationally recognized standard for quality management in the medical devices industry. The standard has a lot in common with the requirements of the Medical Directives (AIMDD, MDD, IVDD). KEMA has transformed the ISO 13485 certification process into an opportunity for you to improve your company’s efficiency and increase profits. Additionally, the ISO 13485 certification can open international doors into new markets because many countries require this certification.
At KEMA, our primary focus is your success in the context of ISO 13485 conformance. To customize our certification services, we align our audit plan with your business goals. By doing so, we assist you in achieving your management objectives. When your facility is due for a quality system audit, the ISO 13485 enables you to combine the quality system requirements with the regulatory requirements. KEMA’s Notified Body auditor, who is also your contact for the Medical Directives (AIMDD, MDD, IVDD) CE certification, will be the lead auditor. There are clear advantages for selecting KEMA:
- KEMA is recognized registrar for the Canadian Medical Devices Conformity Assessment System (CMDCAS) and an accredited body for QSIT inspections for the US market
- All regulatory auditing for medical devices via one service provider: KEMA is able to certify your Quality Management System as well as the product related aspect in one combined audit
- KEMA knows your organization, quality system, and products from CE auditing
- CE certification audits and ISO 13485 auditing are integrated, thus saving overall audit time in your facility
- The regulatory knowledge of the Notified Body auditors will be useful for the ISO 13485 certification
- You have the assurance that your certificate has been issued by one of the leading Notified Bodies worldwide.
More information? Contact us.
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