Danem Test

+41 41 535 64 52

Меню

Medical Devices Quality Management System Certification (ISO 13485)

Independent guidance and technical support to help medical device manufacturers prepare for EU MDR requirements and market access.

Danem Test & Certificate supports medical device and in vitro diagnostic (IVD) organizations with ISO 13485 certification projects, covering the full pathway from initial readiness assessment through certification preparation and audit support activities.

ISO 13485 is an internationally recognized standard for quality management systems in the medical device industry. It defines requirements for ensuring consistent control across the entire product lifecycle, with a strong focus on risk management, traceability, regulatory compliance, and product safety.

our approach to iSO 13458 certification support

The implementation approach is tailored to the organizations’s role within the medical device supply chain, including:

Medical device manufactueres

In vitro diagnostic (IVD) manufactures

Critical suppliers

Contract manufactures

Service providers

Organizations supporting medical device operations

ISO 13485 certification demonstrates that an organization operates a structured quality management system capable of consistently meeting customer expectations and applicable regulatory requirements relevant to medical device activities and scope.

Typical applicable business categories include medical device manufacturers, IVD manufacturers, contract manufacturers, sterilization providers, packaging providers, critical component suppliers, laboratories, calibration providers, logistics operators, and technical service organizations supporting medical device products and operations.

ISO 13485 CERTIFICATION PROCESS

Scope definition & Readiness Review

Assessment of certification scope, operational activities, applicable sites, and current QMS maturity to establish a practical route toward certification readiness.

QMS Alignment & Documentation Review

Alignment of documented information, operational controls, supplier management processes, traceability systems, risk management interfaces, change control procedures, and CAPA processes with ISO 13485 requirements.

Audit Preparation & Certification Support

Support for internal readiness assessments, audit preparation activities, corrective action planning, and coordination of certification audit requirements.

Certification & Continual Surveillance

Upon successful certification, Danem Test & Certificate issues the ISO certificate and conducts scheduled surveillance audits to support continued conformity with ISO 13485 requirements.

join the success

WHY DANEM TEST & CERTIFICATE

CT, hospital, medical equipment certification
  • Global Expertise
    International team supporting certification and compliance projects worldwide

  • Independent Assessment
    Transparent and impartial certification, testing, and audit processes

  • Structured Certification Pathways
    Clear project planning from assessment through approval

  • Technical & Regulatory Knowledge
    Support across certification, testing, regulatory requirements, and market access.

FAQ

ask us
anything

MDR applies to medical devices and certain accessories and software placed on the EU market. Classification depends on intended purpose, risk profile, and applicable MDR rules, which we confirm during the initial review.

Not always. Notified Body involvement depends on device class and applicable route. We help confirm whether Notified Body assessment is required for your device.

Frequent gaps include incomplete clinical evidence planning, weak traceability between claims and evidence, missing post-market surveillance planning, and outdated risk management documentation. Early gap assessment reduces rework.

Often yes, but it typically requires updates and restructuring to match MDR expectations. We help map existing documentation to MDR requirements and identify what needs to be added or improved.

Timelines depend on device class, documentation maturity, clinical evidence needs, and organizational readiness. A structured plan and early gap assessment help make timelines predictable.

GET IN TOUCH

Questions about our certifications or support plans? Let's talk.
Contact Us