ISO 13485 Certification
Quality Management for Medical Devices
Internationally Recognized Certification for Medical Device Quality Systems
ISO 13485:2016 is an internationally recognized Quality Management System (QMS) standard tailored to organizations in the medical device industry. Achieving ISO 13485 certification demonstrates your commitment to quality, safety, and regulatory compliance throughout the entire medical device lifecycle.
Why Choose DEKRA for ISO 13485 Certification?
DEKRA’s audit team consists of experts with extensive experience to accurately assess the compliance of your management system with ISO 13485 standards.
- Trusted Expertise – With over 30 years of experience as a recognized Certification Body, DEKRA provides accurate and reliable ISO 13485 certification services.
- Dedicated Support – We provide a single point of contact for your entire ISO 13485 certification journey.
- Global Reach – DEKRA Medical Services operate directly in 7 countries, offering access to local expertise and key international markets, including the EU, UK, and beyond.
Why ISO 13485 Certification
Having an ISO 13485-certified QMS enhances credibility, expands business opportunities, and meets industry expectations across global supply chains.
- Complete a pre-application form: Provide information about your organization, scope, and current quality management system.
- Receive a detailed proposal: this includes estimated costs, audit duration, timelines, and our terms and conditions.
- Accept the quotation: A dedicated DEKRA project manager and Support Office will be assigned to oversee your ISO 13485 certification process, ensuring effective communication and coordination throughout all stages.
- Submit the formal application: DEKRA will review your submission and finalize a formal agreement with you.
- Comprehensive Audit Plan: A comprehensive audit plan will be prepared, including timelines and scheduling of Stage 1 and Stage 2 audits. The audit plan allows sufficient time for preparation and identification of any issues. The certification audit evaluates the implementation and effectiveness of the quality management system. The audit report may include nonconformities, and an initial report is presented during the closing meeting. Clients must respond with a corrective action plan to address nonconformities.
- Stage 1: Readiness Audit
The stage 1 ISO 13485 audit evaluates your organization’s readiness for the Stage 2 Certification Audit. It covers management system documentation, understanding of ISO 13485 requirements, scope determination, supplier control, internal audit performance, management review and other key elements. It also confirms the planned duration for the Stage 2 certification audit. - Stage 2: Certification Audit
After successful completion of the stage 1 audit and resolution of any issues, a stage 2 audit is scheduled. . This certification audit evaluates the implementation and effectiveness of the quality management system. Any nonconformities are documented in the audit report and aclosing meeting is held. Clients must respond with a corrective action plan to address any nonconformities.
- Verification of Compliance by DEKRA Certification Management
- Final Review: After successful completion of Stage 2 and resolution of all nonconformities, DEKRA conducts a final review.
- Certification: If compliance with ISO 13485 is confirmed, an ISO 13485:2016 certificate is issued, covering your quality management system.
Get ISO 13485 Certified with DEKRA
Join the growing number of ISO 13485 certified companies worldwide and gain a competitive edge in the medical device industry. Contact us today to start your certification process!