ISO 13485 Zertifizierung

ISO 13485 – Quality Management for Medical Devices

ISO 13485 is the internationally recognized standard for quality management systems in the medical device sector. It defines specific requirements for companies that manufacture, distribute, or maintain medical devices, ensuring safety, quality, and compliance with regulatory requirements in this highly sensitive industry.

Certification under ISO 13485 helps companies meet legal requirements for medical devices in many markets. It ensures that all processes – from development to production – are implemented according to the highest quality standards.

ISO 13485 is often required by manufacturers, suppliers, distributors, and service providers in the healthcare industry to ensure compliance with international regulations. The standard aligns closely with regulatory requirements such as the EU MDR (Medical Device Regulation) and FDA guidelines in the USA.

Why is an ISO 13485 certification important?

Regulatory compliance – Many countries require ISO 13485 certification for medical devices.
Ensuring patient safety – Higher quality standards mean lower risks for patients and users.
Improved market and export opportunities – Recognized certification grants access to international markets.
Efficient processes – Optimized production and control processes reduce errors and costs.
Trust among customers and partners – Strengthens your company’s reputation in the medical technology sector.

Experienced certification body

Our independent auditors guide you professionally through the entire process.

Practical & efficient implementation

No unnecessary bureaucracy, only tailored solutions for your company.

Neutrality & transparency

Independent assessments with objective audit procedures.

Long-term support & assistance

We remain at your side even after certification.

Pre-Audit (optional)

A pre-audit can be conducted once to determine whether the company is eligible for certification and what improvements may be necessary.

Documentation Review

An auditor team reviews the management system documentation to ensure that all standard requirements are met.

Certification Audit

The planning and execution are carried out according to the prescribed audit regulations. The management system is thoroughly evaluated.

Certificate Issuance

If full compliance with the standard is confirmed, the client receives the certificate, which is officially recognized and valid for three years.

Surveillance Audit (ISO Only)

After 12 and 24 months, it is assessed whether any changes have been made to the management system and whether all standard requirements are still being met.

Re-Certification

After a maximum of three years, re-certification is carried out. The client undergoes the steps of the initial certification again.