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Quality management for medical products – DIN EN ISO 13485:2016-08

Developing and manufacturing medical products according to ISO 13485

Nowadays, the health and lifestyle market is huge. It’s not just the classic industrial nations of the Western world. The emerging markets of the Asian region regions help their societies to develop evermore the need for scientific and technical innovations which promise better health and a longer life and the same is more and more true for Arabian and African markets as well. Improved living conditions, secure jobs and globally increasing prosperity make people attach more and more importance to their health and likewise “prepare” purposefully for age with regard to physical and mental respects.

However, the lucrative medical products industry is also subject to strict legal control, just like the pharmaceutical market. Those who don’t pay close attention to legal regulations and those who don’t work diligently when it comes down to quality management hardly stand a chance on the market for medical products. In the meantime, it’s not just legal requirements but above all, the quality expectations of the clients which have become too highly developed for companies that don’t perform well enough to be successful. Specifically with respect to medical products, that means they need not only to fulfill their desired purposes in actual practice but also that their applications as such need to pose no danger to patients or users and that the – potentially existing – remaining risks need to be justifiable and acceptable compared to the predicted usefulness of the aforementioned products.

Types of medical products

Especially devices having “physical” impacts on the human body are referred to as medical products compared to medicines having pharmaceutical impacts. Medical instruments, laboratory devices but also surgical instruments like catheters, infusion sets and bandaging materials classically represent this category. Above all, dental products, implants and assistive devices like hearing aids and contact lenses are becoming more and more important today. Of course, walking aids, wheelchairs or preventive stockings can also be classified as medical products in the nursing sector.

Due to the progressive digitalization in medical technology, the software development area has become one of the most crucial sections of medical products on top of that. In that department, it is not relevant whether such software is part of a medical device or if it works in a standalone manner.
A CE label and an according declaration of compliance are required for medical products to be marketable and usable in the EU.

ISO 9001 and ISO 13485

Large parts of ISO 13485 conform to ISO 9001. That has not only the advantage of it generally being based on the most widely used standard. But the establishment of a quality management system conforming to ISO 9001 facilitates obtaining a certification according to ISO 13485 to a massive extent. But during the ISO 13485:2016 revision, some relevant modifications that did not follow ISO 9001 took place so that the standards can be assumed to develop in a slightly different way in the future. The standard for medical products is especially aimed more strongly at protecting patient and health data and it is also more strongly considerate of requirements on software products or software contained within products. Of course, specific requirements on maintenance, clinical validation or cleaning are likewise more pronounced, though.

In practice, it is also important that ISO 13485 requires that the QM system be upheld and accordingly, not necessarily improved on a continual basis.

As the anticipated model life of medical products tends to become shorter and shorter, investments can’t really be economized thereby either, though.

ISO 13485 with PeRoBa Management Consultancy in Munich

PeRoBa in Munich has long-term experience with respect to quality management and therefore, we are your specialized contact persons for all your questions related to the ISO 13485 standard for medical products. Our holistic approach and our expertise on quality management in mechanical engineering and software development enable us also very specifically to develop sustainable and successful QM conceptions in those departments. We will be happy to help you in a targeted and purposeful manner on your way to obtaining a successful ISO 13485 certification.

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