ISO 13485

​ISO 13485 is the international standard for companies that design, manufacture, distribute or service medical devices. ISO 13485 certification demonstrates that your organization meets the stringent quality and safety requirements of the medical industry, ensuring complete control over processes and full product traceability.

It is the essential standard for companies that want to enter international markets, collaborate with global manufacturers or comply with European and international regulations on medical devices.

Why do you need ISO 13485 certification?

The medical device industry is one of the most regulated in the world. ISO 13485 helps organizations demonstrate compliance with legal and technical requirements, reducing risks and increasing the trust of customers, partners and authorities.

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Key benefits of ISO 13485:
Compliance with the requirements of the EU Medical Device Regulation (MDR)

Strict control of processes, documentation and traceability

Reduction of risks of defects, complaints or medical incidents

Increased trust from customers and regulatory bodies

Access to international markets and collaborations with global manufacturers

Efficient process and continuous improvement of product quality

What does ISO 13485 certification entail?
ISO 13485 assesses how the organization manages critical processes: design, production, sterilization, storage, distribution, maintenance, post-market monitoring and risk management.

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How long does it take and how much does ISO 13485 certification cost?
The duration depends on the complexity of the medical products and the number of processes involved (production, distribution, service, etc.). In general, certification is completed within a few weeks. The cost is influenced by the field of activity, technological risks and the size of the organization.

We offer you a personalized offer within 24 hours.

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Why choose Certify for ISO 13485?
Fast, clear and personalized process for the healthcare industry

Consultation included and complete guidance for MDR compliance

Audit performed by internationally accredited certification bodies

Competitive prices for SMEs and medical startups

Continuous support before and after obtaining the certificate