ISO 13485 the standard for medical devices

What is ISO 13485

ISO 13485 is an international standard for quality management systems developed for organisations that design, manufacture, install or maintain medical devices.

The standard focuses on complying with regulatory requirements and ensuring the safety and quality of medical devices throughout their life cycle, from band-aids to pacemakers, with the goal of improving patient safety.

For companies in the medical devices industry, ISO 13485 is essential to demonstrate that their processes meet the stringent requirements of regulators such as the FDA and the European Union.

NBN EN ISO 13485:2016

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Medical devices - Quality management systems - Requirements for regulatory purposes

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Benefits of ISO 13485

In accordance with European requirements

You can be sure that your medical devices meet all strict European safety and quality requirements.

Conforms to CE marking and MDR 93/42/EEC

Your products are in line with CE marking and MDR 93/42/EEC. This confirms that your product meets all European safety, health and environmental standards.

Clarity for producers and buyers

The ISO 13485 quality standard provides clarity for both producers and buyers, promoting cooperation and understanding.

Protection of the end consumer

ISO 13485 protects your end consumers thanks to the guaranteed safety of your products, even after sale.

Continuous improvement

The focus on quality management fosters a culture of continuous improvement, leading to innovation and better long-term performance.

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The quality, conformity and safety of our equipment is essential. Because IBA operates all over the world, our equipment needs to meet the requirements of market authorities in different countries. International as well as local standards are an indispensable tool to ensure that we meet all these legal requirements.

Caterina Brusasco

R&D Compliance Expert at IBA.

ISO 13485 certification

Are you a manufacturer of medical devices? Then it is interesting to obtain ISO 13485 certification.

Why ISO 13485 certification?

You prove that you can provide safe medical devices.
Being a certified organisation increases your chances of securing contracts with large organisations.
You improve your internal processes and decision-making, resulting in greater efficiency and effectiveness.
Certified organisations foster a culture of continuous improvement, which encourages innovation and quality assurance.
You prove that your organisation is actively committed to safety and quality, reinforcing the trust of customers and partners.
You meet the requirements of both clients and regulators, minimising legal risk and promoting compliance.

Do you want to find out more about certification, which institutions certify and how to prepare your organisation for certification? Learn more on our certification page or in our white paper.

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Collaborate on ISO 13485

Would you like to contribute to the future of the ISO 13485 standard and other standards related to medical device quality management?

beMedTech acts as sectoral operator for the ISO/TC 210 standards committee and is the contact for anyone wishing to contribute to these standardisation activities.

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Frequently asked questions about ISO 13485

How do I access the ISO 13485 standard?

You can buy the ISO 13485 standard in our shop. Please note this is for personal use only. Standards are copyright protected. To make the standard available to your entire organisation, it’s best to take out a subscription to the NBN platform. This allows you to use copyright compliant standards throughout your organisation. Check out our solutions here.

We also offer a ISO 13485:2016 Handbook with clear guidelines, support and practical examples to comply with the standard.

Is ISO 13485 mandatory?

ISO 13485 is not mandatory, but it's crucial for companies in the medical devices industry. Certification helps you meet legal and regulatory requirements, which is often necessary to get products to market.

In some cases, such as working with large customers or entering certain markets, ISO 13485 certification may even be a requirement. It's therefore highly recommended for companies that want to ensure the quality and safety of their products and gain a competitive advantage.

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ISO 13485 - Quality management of medical devices