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 6 countries, offering access to local expertise and key international markets.
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 and submit the formal application. A dedicated DEKRA project manager will be assigned to guide you through the certification process and ensure clear communication at every stage.
- An audit plan is developed, including the scheduling of Stage 1 and Stage 2 audits. The plan allows time for preparation and may identify potential issues in advance.
- Stage 1: Readiness Audit
Assesses your documentation, understanding of ISO 13485 requirements, internal audits, management review, and overall readiness for Stage 2. - Stage 2: Certification Audit
After successful completion of the stage 1 audit, the stage 2 audit evaluates the implementation and effectiveness of your quality management system. Nonconformities are recorded, and corrective actions must be submitted.
- After successful completion of Stage 2 and closure of any nonconformities, DEKRA performs a final review. If compliant, the ISO 13485:2016 certificate is issued.
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!