Quality Management System EN ISO 13485 certifications
Implementing and maintaining a robust quality management system (QMS) for your medical devices, products and services provides an indispensable foundation on which to build your business. EN ISO 13485 certification of your QMS demonstrates your commitment to operating at a global standard.
The EN ISO 13485 certification process includes on-site audits to verify the capability and reliability of your quality management system. Our experts assess both the practical application and degree of effectiveness in the areas of design, development, production and customer care.
As a well-respected and globally recognized Notified Body, we hold extensive accreditations and are able to serve you at regional facilities worldwide. Our one-stop- shop portfolio consists of comprehensive services designed to accommodate your unique circumstances and business needs
Four steps to EN ISO 13485 certification:
1. Optional preliminary audit
Voluntary site inspection and quality management documentation review assessing your readiness for full-scale Phase I & II auditing.
2. Audit: Stage I
Assessment of certification eligibility determined by results of on-site audit, quality management documentation analysis and business assessment.
3. Audit: Stage II
On-site evaluation of quality management system for excellence in areas of applied practice and efficiency.
4. Certification
Official confirmation certifying the integrity of your quality management system and complete compliance to the standards.
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