Adequate quality control is absolutely necessary for the manufacture of medical devices. What are the legal requirements and relevant standards that apply in medical technology? Which tools ensure quality in practice?
Like medicines, medical devices are also subject to strict quality assurance requirements. This applies to certification and approval procedures as well as the quality management of production and processes. In Europe, a medical device is defined by the EU Medical Device Regulation as per 26 May 2021, which must be complied with by the manufacturer. Only when the current regulations are met can the product be marketed within each country and the EU.
The following sections explain what medical technology is and what a medical technology product really is (see also our article What is medical technology?). This is followed by an attempt to define the term “quality” in relation to medical devices. On the basis of these theoretical considerations, the next section then deals with quality management and quality assurance of medical devices. In addition to the objectives of a quality management system, its legal bases and also the possibilities of being certified according to various quality management systems in medical technology are examined. There is also quality management software that can be used for implementation and certification of the systems.
Definition of the term “medical device”
Medical devices have a medical purpose and are intended for human use. While drugs primarily have a pharmacological, immunological or metabolic effect, medical devices achieve their intended effect primarily in a physical way.
“Medical device” means any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following specific medical purposes:
- diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease,
- diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or disability,
- investigation, replacement or modification of the anatomy or of a physiological or pathological process or state,
- providing information by means of in vitro examination of specimens derived from the human body, including organ, blood and tissue donations,
and which does not achieve its principal intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its function by such means.
The following products shall also be deemed to be medical devices:
- devices for the control or support of conception;
- products specifically intended for the cleaning, disinfection or sterilization of devices as referred to in Article 1(4) and of those referred to in the first paragraph of this point.
Quality in medical technology
The word quality is derived from the Latin term qualitas and can be translated as “as it is”. In medical technology as such, there is no fixed and generally applicable definition of the term. Consequently, quality is a relative concept.
For this reason, it is necessary that the term quality is defined specifically in relation to various medical devices. Each definition covers all aspects that apply to the product but also the entire product development process. The definition of the term quality that is relevant to medical technology can be found in the quality standards:
ISO 9000: 2015, a family of standards, describes the fundamental concepts and principles of quality management which are universally applicable to organizations seeking success through their management system, supply chain logistics, improving internal communications, and more.
ISO 9001: 2015 specifies requirements for a quality management system when an organization needs to demonstrate its ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements.
ISO 13485: 2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.
Requirements for safety and performance of medical devices
A basic requirement is that medical devices must meet specific performance and safety requirements in Sweden and within Europe, which are also called “basic requirements”. An assessment of compliance with these requirements determines whether a medical device meets these basic requirements. As a rule, the manufacturer of a medical device makes the assessment of conformity himself and at his own risk. The assessment covers the following areas:
- Process for risk management
- Clinical evaluation
- Risk benefit analysis
If the conformity assessment procedure establishes that a medical device meets all the requirements, the manufacturer may affix the CE marking.
Manufacturers of Class I products certify by their declaration of conformity that the product meets the requirements of the regulations.
However, the involvement of a notified body is required for products that have a measuring function (class Im), are sterile (class Is) or are reusable surgical instruments (class Ir). In principle, these bodies can be independent certification bodies, appointed and supervised by a state institution in all Member States.
A notified body within the EU is an organization designated by a Member State to assess compliance with the applicable essential technical requirements for certain products before they are placed on the internal market. These essential requirements are published in European directives or regulations.
Class II and III always require the involvement of a notified body (see also our article on Classification of Medical Devices).
The manufacturers of each medical device can, however, freely choose the notified body that will carry out the evaluation of their product in Europe.
A medical device that is CE marked can be distributed throughout the European area of cooperation. It should be noted, however, that the time-limited validity of the certificates issued by a notified body after assessment of conformity must be regularly renewed. From 26 May 2021, all medical devices must be certified in accordance with the new European Regulation on Medical Devices (MDR). MedTech Europe has produced a poster with a flow chart (in English) that shows all the requirements within MDR and which can be downloaded here.
Quality management system (QMS) in medical technology
A quality management system as proof of the quality of a medical device is a requirement of more and more customers. Many customers no longer consider it sufficient if only a quality control is carried out, for example as part of a final inspection by the manufacturer. Instead, it is necessary to monitor the quality requirements over the entire production cycle – from the delivery of materials to delivery to the customer.
And exactly this is the task of the quality management system (QMS). QMS defines the quality goals on the one hand and talks on the other hand about which measures should be used to achieve the respective quality goals. The scope, level of detail and individual parts of QMS in medical technology are product dependent. This means that they are adapted to the medical device, its area of application and the specific requirements placed on it. The decision to work with QMS is made by the company management and the implementation is then ensured by the respective departments within the company, which is the prerequisite for the quality management of medical technology products to be used throughout the company.
According to ISO 9001, the quality management system has the task of ensuring the management and control of an organization in terms of quality. In other words: a quality management system makes it possible to design processes so that the medical device meets the customer’s requirements in terms of quality. In addition, it ensures that the legal requirements are also met.
These can be summarized as follows:
- The quality of the medical device must be such that it fulfills its intended purpose as flawlessly as possible.
- The medical device must be of a quality that ensures that the risks of its use are acceptable to both people and the environment.
Quality management in medical technology mainly refers to product and customer-related processes in the company. These include procurement, development, production, sales, marketing, delivery, installation or assembly, maintenance and customer service.
Objectives for a quality management system (QMS)
A quality management system can include many services and products. Due to the fact that medical devices are used on humans, they have to meet high expectations in terms of reliability and safety.
Based on regulations and laws, the legislator guarantees a high level of protection for patients, users and third parties. Therefore, a medical device must be able to fulfill all the functions described in a correct and reliable manner. Only then does the product meet the high safety criteria and does not pose a risk to health.
Manufacturers of medical devices must use the latest technology to minimize any potential risks. For this reason, a quality management system is important to ensure quality in the product responsibility area. Although the implementation of a quality management system involves large costs for the company and takes a lot of time, there are long-term savings because the introduction of the system can shorten development times, optimize processes and avoid errors.
Legal bases for a quality management system
26 May 2021, the new EU MDR came into force. Due to the circumstances discussed above, the Directive for medical devices belonging to specific risk classes requires a quality management system. This will be used in the development, manufacture and marketing of medical devices. The directive distinguishes between three categories of quality management systems in medical technology:
- A complete system for quality control: in this category, the quality management system is used both for design and for production and final control of each medical device.
- Quality assurance of production: the quality management system must ensure quality and is intended partly for the production and partly for the quality and final control of medical devices.
- Quality assurance of the medical device: a quality management system is mandatory for all inspections of each medical device.
In addition, depending on the intended conformity assessment or risk class, a certification of the quality management system may be absolutely necessary in medical technology.
In order for a quality management system to be certified, an application for quality management certification must be submitted to a notified body. A two-step audit process is then carried out, which means that an auditor checks whether the company meets the requirements and also checks the technical documentation for the medical device.
Depending on the countries in which a medical device is to be marketed, the manufacturer must design the quality management system so that, in addition to EU regulatory requirements, it also meets the requirements of other countries where it is to be sold. This is the case, for example, if the manufacturer seeks US FDA approval for the product.
Both the US and European markets have guidelines that correspond to quality assurance in accordance with GMP (Good Manufacturing Practice). In addition, manufacturers of medical devices must inform themselves about their suppliers’ quality management systems. Because even when it comes to purchased product components in medical technology, it is important to be able to certify the quality of the products.
In general, the certification process is based on qualification or validation. This is divided into the following phases based on the life cycle model:
- Design Qualification (DQ)
- Installation Qualification (IQ)
- Operational Qualification (OQ)
- Performance Qualification (PQ)
Digitization: quality management and Industry 4.0
Industry 4.0 has long since come to influence quality management because the use of quality management software can make many things easier. Computer-aided quality (CAQ) is computer-aided quality assurance performed with specific CAQ software. By implementing a CAQ system, the entire production process in medical technology can be followed and it includes both services and operational activities. Process data in each company is made visible and can be evaluated with predefined indicators for quality assurance.
Manufacturers of medical devices can have these certified according to ISO 9001 and according to ISO 13485. To ensure the quality of medical devices, ISO 13485 Medical devices – QMS – Requirements for regulatory purposes is usually the most important option. This standard defines the requirements for the quality management system of the manufacturer of medical devices and related services.
The application of the standard is intended to ensure that the manufacture and packaging of medical products and the risks of their use do not exceed an acceptable level for humans and the environment. For this reason, manufacturers of medical devices using a quality management system in accordance with ISO 13485 may also demonstrate that their product meets the essential requirements for quality assurance. The quality assurance of measurement technology, tools and production also falls into this category, as does the quality assurance of incoming and outgoing goods. A quality control diagram is often used to check whether the quality management meets the requirements.
In summary, it can be said that a structured and comprehensive quality management system is an excellent tool for manufacturers, suppliers and service providers in the medical technology sector to optimally meet the quality requirements placed on a product. If a sophisticated quality management system is used, the company’s structures, processes and products can also be optimized. A validation of the quality management is used to determine whether the system meets the specified requirements in practical use.
However, it must also be pointed out that the implementation of a quality management system in a company involves a huge amount of extra work for the employees. In addition, a new way of thinking is sometimes required. But it is also a fact that system-based quality management will pay off for the company. The company decides for itself whether a quality representative, a quality manager or a quality engineer is needed to implement the planned changes.
AMB is certified according to the quality standards ISO 9001, 13485 and 14001 and where 13485 refers to “Manufacture of plastic products through injection molding, painting and assembly, surface treatment for EMC shielding and sterile packaging in clean rooms.”
This aritcle is based on the article Qualitätsmanagement in der Medizintechnik: Definitionen, Ziele und Tools by Romy Schmidt and Peter Reinhardt, and has ben translated and has been translated and supplemented by Jörg Hinz, M. Sc.