Quality management (QM) is a crucial part of the manufacture and distribution of medical devices. It ensures not only compliance with legal regulations, but also the safety and efficacy of the products. In an industry where patient welfare and public health are at stake, a robust QM system is essential.
Quality management encompasses all measures and processes that ensure that a product fulfils the specified requirements. For medical devices, this means in particular
- Patient safety: minimising risks through careful planning and monitoring of product quality.
- Compliance with legal regulations: Ensuring that products fulfil the requirements of international standards and national laws, such as the EU Medical Device Regulation (MDR) or US FDA regulations.
- Continuous improvement: Regular review and optimisation of processes to reduce errors and increase product quality.
RELEVANT STANDARDS AND REGULATIONS FOR MEDICAL DEVICES
International standards and legal requirements form the basis for QM in the medical device industry.
ISO 13485
This standard defines the requirements for a QM system specifically for medical devices. It serves as a global standard.
ISO 13485 is an internationally recognised standard that defines the requirements for a quality management system for manufacturers and suppliers of medical devices. It serves as the basis for ensuring that medical devices fulfil the applicable legal and regulatory requirements. The standard places particular emphasis on aspects such as risk management, product conformity and continuous improvement. Companies that are certified to ISO 13485 demonstrate that they have a robust system in place to ensure the quality and safety of their products at every stage of the product life cycle. This includes development, production, installation and service. The standard is an important standard for accessing global markets and emphasises the commitment to maintaining the highest quality standards in the medical device industry.
MEDICAL DEVICE REGULATION (MDR)
The MDR regulates the entire life cycle of a medical device in the EU, from development to market surveillance.
The Medical Device Regulation (MDR), officially known as Regulation (EU) 2017/745, is a binding European Union regulation that governs the safety and performance requirements for medical devices. It came into full force on 26 May 2021 and replaces the former Medical Device Directive (MDD). The MDR aims to strengthen the protection of patient safety by placing stricter requirements on the authorisation and monitoring of medical devices. It places particular emphasis on risk management, clinical evaluations and the traceability of products. It also includes new categories such as devices without an intended medical purpose and requires extended technical documentation. Manufacturers, importers and distributors must comply with the new regulations in order to be able to offer their products on the European market.
FDA 21 CFR PART 820
In the USA, these regulations govern the Quality System Regulation (QSR) for medical devices.
The FDA 21 CFR Part 820 is a legal regulation of the US Food and Drug Administration (FDA) that defines the quality management system requirements for manufacturers of medical devices in the United States. Also known as the Quality System Regulation (QSR), it stipulates that companies must implement a comprehensive system to ensure the quality and safety of their products at every stage of the life cycle - from development to manufacturing and maintenance. The core requirements include process controls, documentation, traceability and error correction measures. Compliance with 21 CFR Part 820 is crucial in order to be able to authorise and distribute medical devices on the US market. The regulation serves to protect patients and ensure high quality standards.
STRUCTURE AND ELEMENTS OF A QUALITY MANAGEMENT SYSTEM FOR MEDICAL DEVICES
An effective QM system for medical devices comprises the following key areas:
A) RISK MANAGEMENT
According to ISO 14971, risk management is a central component of QM. It requires the identification, assessment and control of risks throughout the entire product life cycle. It must be possible to react quickly and economically to recognised risks and problems.
B) DESIGN AND DEVELOPMENT PROCESSES FOR MEDICAL DEVICES
A structured approach to product development ensures that the products fulfil the requirements and can be validated. Medical devices must fulfil their tasks precisely and be both robust and reliable.
C) SUPPLIER MANAGEMENT
The selection and monitoring of suppliers is crucial, as they are often responsible for key components or processes. There is also a constant trend towards modularisation or even outright licensed production of medical devices. It must be possible to effectively manage these risk areas.
D) PRODUCTION AND PROCESS CONTROL
It must be ensured that production takes place under controlled conditions in order to guarantee consistent quality. Medical devices are subject to strict regulatory requirements as they can directly affect the health and well-being of patients. They are also often used in areas where patients already have health problems and therefore have to fulfil special hygiene and safety requirements.
E) POST-MARKET SURVEILLANCE
After market launch, continuous surveillance is required to recognise and rectify problems at an early stage.
Product safety surveillance is used to identify and assess risks or side effects that may occur during use. A performance evaluation ensures that the medical device fulfils its intended function under real-life conditions. Findings from market surveillance are incorporated into the further development of the product and are used for improvement and innovation. The collection of data to review and adjust the risk assessment throughout the product life cycle serves as future input for risk management.
CHALLENGES, OPPORTUNITIES AND FUTURE PROSPECTS
The implementation of a QM system for medical devices is complex and cost-intensive, but offers numerous advantages, such as confidence building (a robust QM system strengthens the trust of patients, doctors and partners), competitive advantages (certified quality standards can facilitate market access) and responsiveness (effective QM systems enable a rapid response to regulatory changes or market requirements).
With increasing digitalisation and automation in the medical device industry, new technologies are gaining in importance. These naturally include artificial intelligence (AI) for optimising quality controls and predicting errors. But blockchain and big data also hold great promise here. On the one hand, ensuring traceability in the supply chain can be better guaranteed, but improving post-market surveillance by analysing large amounts of data also appears to make sense in the long term.
PEROBA QUALITY MANAGEMENT FROM MUNICH
CONSULTING, IMPLEMENTATION, AUDITS AND QM TOOLS FROM A SINGLE SOURCE
Quality management is essential for the development and marketing of medical devices. A well thought-out and consistently implemented QM system not only protects patients, but also contributes to the long-term competitiveness of a company. In an industry characterised by innovation and regulation, QM remains a key success factor.
PeRoBa GmbH Munich is a service provider with many years of experience in quality management, especially in the automotive, mechanical engineering and pharmaceutical sectors. We help with all important standards on the way to certification or re-certification. We also work closely with universities and research institutes. Managing Director Dr Scherb teaches as a lecturer at the Hamburger Fern-Hochschule, the FOM in Munich and is also a speaker at the TÜV-Süd Akademie, the Bildungswerk der Bayerischen Wirtschaft and many other institutions.