What is quality management in medical technology? Definitions, goals and tools

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.