Quality management in medical technology: focus on safety and efficiency

Medical technology is one of the most demanding and innovative industries in the world. This makes efficient quality management (QM) crucial to ensure both product safety and compliance with strict regulatory requirements. For manufacturers of medical devices, QM is not only a legal obligation, but also the basis for trust and market success.

QM in medical technology encompasses all processes that are necessary to manufacture safe, effective and reliable products. A good QM system ensures that errors are minimized, risks are controlled, and processes are continuously optimized. In addition to product safety, traceability also plays a central role – from production to the end user.

Manufacturers must comply with many standards and legal regulations. In Europe, the Medical Device Regulation (MDR) is of central importance. It stipulates that medical devices must meet the highest safety standards and be comprehensively documented. There are also various QM-relevant standards.

Pramodh Kumar, Project Manager, gives an overview of the standards that are applied in his company, ET Elastomer Technik GmbH: "ISO 9001 ensures global quality management system standards for customer satisfaction. ISO 13485 is essential for maintaining consistent quality in the design, development, and production of medical devices. ISO 14001 focuses on minimizing environmental impact."

Other relevant regulations include ISO 14971, which deals with risk management, as well as specific requirements of the US FDA for market access in the USA.

An effective QM system is based on several pillars. Seamless documentation and product traceability are key. These ensure that all process steps and decisions remain traceable. Risk management is equally important: manufacturers must identify potential risks at an early stage and take appropriate measures to minimize them.

The training and qualification of employees is another decisive factor. Regular training is the only way to ensure that the workforce is informed about current standards and procedures. At the same time, companies should continuously review and improve their processes – for example by using the PDCA cycle (Plan-Do-Check-Act) or similar methods.

COMPAMED exhibitor Freudenberg Medical also relies on a wide range of QM measures at its eleven locations worldwide. Laura Kirstein, Director Marketing and Communications, lists these to include "clear product specifications that are agreed with the customer, qualified raw materials and suppliers that are aligned with the product risk, validated manufacturing processes and qualified tools and equipment." Written process descriptions and work instructions are also important, as are comprehensive hygiene management to ensure product safety and testing and approval processes by the quality department.

The technological development of medical technology also poses new challenges for QM. The introduction of digital technologies such as artificial intelligence (AI) and connected devices (IoT) creates additional requirements for product safety and data integrity.

Another issue is cyber security: connected medical devices must not only be functionally protected, but also protected against potential cyber attacks. This requires close integration of QM and IT security measures.

In view of the high complexity of QM, manufacturers have a wide range of consulting services at their disposal. Specialized consulting companies offer support in the implementation and optimization of QM systems. Certification bodies can also provide valuable services, especially when preparing for audits.

COMPAMED also offers an ideal platform for finding out about current trends in quality management. Here, manufacturers can exchange ideas directly with experts and providers of QM solutions.

With a well-thought-out quality management system, companies not only ensure the quality of their products, but also their competitiveness. Laura Kirstein also knows that good quality management is a competitive advantage: "Our quality controls include customer-specific test methods and additional tests that go beyond regular standards to ensure the highest product quality."