ISO 13485 certification for medical devices

Anyone who develops medical products bears a lot of responsibility – for the safety of patients, the trust of medical teams and compliance with strict rules. Here, “good” is not enough. Quality must be demonstrably right: in materials, processes and documentation. ISO 13485 is a standard that not only demands reliable standards, but also permanently anchors them in the company.

Whether for diagnostic devices, implants or in-vitro diagnostics – processes must be clearly regulated in medical technology and in the manufacture of medical devices. As an internationally valid standard, ISO 13485 describes how a functioning quality management system for medical devices must be structured. The requirements cover all steps: from development and manufacture to technical documentation. They serve as a basis for regulatory purposes worldwide.

Manufacturers, suppliers, providers – anyone who develops, produces or sells medical devices benefits from certification. In many countries, it is not only helpful, but also the entry ticket to the market. Without valid certification, approval and business relationships can quickly come to a standstill.

Different requirements apply depending on the market – but in many cases there is no way around ISO 13485. Although it is not required by law everywhere, it is often accepted as a prerequisite for demonstrating compliance with regulatory requirements. In Canada in particular, but also in the EU or the USA, certification provides the necessary scope for smoother market access and supports the implementation of EU directives.

A clearly structured quality management system brings more than just a certification mark. Certification strengthens your position on the market, helps with risk assessment and ensures greater transparency and security internally. Those who are certified can control routines better and act more confidently during inspections or approvals – a real competitive advantage.

ISO 13485 brings structure to an environment where every detail matters: the safe and effective manufacture and smooth distribution of medical devices. It describes how your quality management system must be structured – in such a way that it not only functions internally, but also meets the requirements of international authorities.

This is what the standard specifies:

The standard is formulated in such a way that it can be flexibly adapted to different companies – regardless of whether you produce, develop or provide important partial services in the background. The important thing is that what you do must be organized in a comprehensible, safe and compliant manner.

If you want to be certified according to ISO 13485, it is not enough to have a few documents ready. The standard requires a quality management system that works on a day-to-day basis – consistently. The aim is to identify risks, clarify responsibilities, safeguard processes and reliably implement regulatory requirements.


The requirements include:

When it comes to ISO 13485 certification, don’t just count on the audit itself – the entire process begins much earlier. It usually takes a good six months from the first planning step to the certificate being issued. Depending on how far your quality management system is already developed, it can also be quicker – or take a little longer. It is important that you take the necessary time for internal preparations: Define processes, compile documentation, clarify responsibilities. If you take a structured approach here, you will save time later during the audit.

The investment in certification should not be underestimated – but it is worth it. For small and medium-sized companies, the total costs are between 20,000 and 60,000 euros. This includes the pre-audits, the main audit and the document review. If you also rely on external consulting, additional expenses may be incurred – but you save on internal company costs.

Whether it’s temperature-sensitive reagents, fully equipped rental devices for measurements or the technical setup of medical systems directly in clinics: our Healthcare-Solutions and services for In-vitro-Diagnostics are consistently aligned with the requirements of ISO 13485. This ensures that you can rely on tested processes, reliable quality and a cooperative partnership – from the first delivery to long-term operation.

LGI offers customized healthcare solutions and takes over the complete management of your demand chain – from storage to reprocessing. With over 50 locations, certified quality and a broad service portfolio, we are your strong partner throughout Europe. Contact us now to find out more!

ISO 13485 specifies the requirements for a quality management system in medical technology. The standard shows: Everything here is structured, safe and compliant – from product development to delivery. Those who are certified create trust, meet international requirements and can serve markets such as the EU, Canada or the USA more easily.

ISO 13485 is aimed at companies that are involved in the development, manufacture or distribution of medical devices – either directly or as a supplier. Components, materials and accompanying services can also be part of the certification. It is crucial that all steps in the life cycle of a product are covered: from the initial idea to production and delivery. Whether you produce or supply yourself – your quality management must be traceable. Exactly which areas of application are certified – such as specific products, processes or company divisions – depends on your operational reality.

ISO 13485 regulates quality management specifically for medical devices – with a clear focus on safety and the legal requirements of the industry. ISO 9001 is cross-sectoral and sets out more general requirements. It is broader in scope, but not equivalent: ISO 13485 is the standard of choice for manufacturers in the medical sector.

The abbreviations in front of ISO 13485 often cause confusion – but the explanation is simple: ISO 13485 is the international standard. If it is adopted throughout Europe, it is called EN ISO 13485, and if Germany adopts it into its own set of standards, it is called DIN EN ISO 13485: DIN EN ISO 13485. The content remains the same, only the scope changes.

You are generally allowed to outsource parts of your quality management system – however, ISO 13485 requires that you strictly monitor and control outsourced processes. You must assess the risks, make written agreements with service providers and ensure that they work just as reliably as you do. This means that your certificate remains valid even if you outsource.

A functioning quality management system brings more than just a seal of approval. With ISO 13485, you create clear internal processes, reduce risks and appear more confident during audits. At the same time, you strengthen your position on the market – because those who are certified offer customers and authorities proven safety and long-term reliability.