Certifications build trust – a crucial factor when it comes to medical devices. EN ISO 13485 is the international standard for quality management systems for medical devices. We examine your quality management practices for medical devices, focusing on design and development, production, customer service, and assembly. Benefit from the positive effects of a quality management system: lean processes, efficient work flows, and international recognition.

EN ISO 13485 certification by the experts at TÜV Rheinland allows you to:

• Communicate your high standards of quality
• Gain a competitive edge thanks to independent certification
• Use our accreditation as a notified body for all your medical devices
• Benefit from our wealth of international experience in the medical devices market

• EN ISO 13485 certification for your quality management system
• EN ISO 13485 certification for processing of medical devices

MDSAP program covering the following regulations:

• Australia: The Therapeutics Goods Administration – TGA
• Brazil: The Brazilian National Health Surveillance Agency - ANVISA
• Canada: Health Canada - CMDCAS
• United States: U.S. Food and Drug Administration’s Center for Devices and Radiological Health
• Japan: The Ministry of Health, Labour and Welfare (MHLW) and Pharmaceutical and Medical Devices Agency (PMDA)

1. Optional Preliminary Audit
Preliminary assessment during which we inspect your site and review your quality management documentation.

2. Initial Certification Audit: Phase 1
We audit your site to determine whether you are eligible for certification or analyze all the required information on your company. We review your quality management documentation for compliance with EN ISO 13485.

3. Initial Certification Audit: Phase 2
On-site, we examine how your quality management system is applied in practice and evaluate how effective it is.

4. Certificate
If you meet all the criteria, we issue a certificate confirming compliance with standards and the integrity of your quality management system.

EN ISO 13485 certification gives you advantages worldwide, not just on the European market. This certification is a prerequisite for marketing your products in other international markets.

Did you know? Neither a decision on granting certification nor any change of the certificate status (e.g. maintaining, renewing, refusing, suspending, restoring or withdrawing certification as well as expanding or reducing the scope of certification) is made by a single person! We always apply the four-eyes principle: The evaluation of the audit team /product expert is followed by a separate review and decision.

SNI ISO 13485: 2016 specifies requirements for quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customers requirements and regulatory requirements applicable to medical devices and related services. The primary objective of ISO 13485:2016 is to facilitate harmonized medical device regulatory requirements for quality management systems. This international standard defines requirements of quality assurance systems for the design/development, production, customer service and assembly of medial devices.

Our experience as “Notified Body” for medical products LSSMMAK (Lembaga Sertifikasi Sistem Manajemen Mutu Alat Kesehatan) is a guarantee for well-founded monitoring of your quality management system in accordance with ISO 13485:2016.

SNI ISO 13485:2016 is applicable to organizations providing medical devices, regardless of the type or size of the organization.

• Active Medical Devices
  • Electro-medical (non-implantable, non-radiation/thermal therapy)
  • Software
• Non-active Medical Device (Implants/ Non-implants
  • Plastics
  • Metals
  • Textiles and fibers
  • Sterilized products

Certificate Valid List

Certificate Suspend List