Medical Devices Quality Management System ISO 13485:2016
ISO 13485:2016
Medical Devices Quality Management System
Accredited by EGAC
ISO 13485 specifies quality management requirements for organizations involved in the design, production, installation and servicing of medical devices.
Certification by AMY International gives your customers, partners and regulators independent assurance that your organization meets the requirements of ISO 13485:2016.
- Supports regulatory approval in many markets
- Consistent, safe and effective devices
- Strong risk management across the product life cycle
- Confidence for healthcare customers
- Proposal & agreement
You accept our quotation and we sign the certification agreement. - Gap analysis (optional)
A pre-assessment that shows how ready your system is before the formal audit. - Stage 1 audit
Documentation review and readiness check at your site. - Stage 2 audit
On-site audit confirming the system is implemented and effective. - Certification decision
Independent review of the audit and issue of your certificate, valid for three years. - Surveillance audits
Yearly audits in the first and second year to keep the certificate valid. - Recertification
A full audit before the three-year cycle ends to renew certification.
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Send us a few details and we'll prepare a proposal for ISO 13485:2016 certification.
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