Editor’s note: Halina explains why compliance with medical device standards is essential for medical device manufacturers and gives examples of the most important international medical device standards set by the International Organization for Standardization (ISO). If you are unsure of how to identify the applicable international medical device standards for the device you are marketing or planning to implement, we invite you to contact the ScienceSoft team. healthcare IT consulting.
The global medical device market stood at $ 432.23 billion in 2020 and is expected to reach $ 657.9 billion for 2028. The main drivers of the market are the growing awareness of the general population in the field of telemedicine and the increasing prevalence of chronic disorders.
The high level of consumer interest in smart medical devices, the special attention of regulatory authorities and the resulting competition in the market forced Manufacturers pay special attention to the quality of their products. The safety and efficacy of medical devices designed to monitor patients ’health, prevent and manage disease are guaranteed by compliance with medical device standards. In addition, compliance with the product with international standards helps the manufacturer to improve consumer confidence and safety.
For medical device manufacturers, compliance with international standards is an opportunity to enter the global market. Typically, the name of the standard is indicated by a combination of a few digits and several numbers. The letters at the beginning of a standard are an abbreviation of the issuing organization, the digits before the colon are the number assigned to the standard by its developers, and the digits after the colon are the year of issue.
ISO standards
ISO 13485: 2016 is the leading quality management system (QMS) standard for medical devices and software as a medical device. It is intended to ensure that medical devices are designed, manufactured, delivered and disposed of when necessary.
ISO 9001: 2015 is the general directive for quality management and is used by medical device manufacturers to control the quality of medical device production.
ISO 27799: 2016 sets out the requirements for medical device manufacturers to maintain the confidentiality and security of the personal health information of patients who will use the medical device.
ISO 14001: 2015 requires medical device companies to implement an environmental management system that helps save energy and reduce waste in the manufacture of medical devices.
ISO 50001: 2018 it helps medical device manufacturers establish an energy management system that allows manufacturers to continuously improve energy efficiency.
ISO 14971: 2019 describes terminology, principles, and a process for risk management of medical devices, software as a medical device, and in vitro diagnostic medical devices.
ISO 45001: 2018 defines the requirements for safety and health management systems that can be used in the medical device industry to reduce accidents at work and related liability issues.
ISO 15223-1: 2016 refers to the symbols that are provided for the labeling of medical devices and that can also be used in the attached documentation of a medical device and its packaging.
ISO 16142-2: 2017 Lists and defines the essential principles of safety and performance of medical devices, identifies standards and guidelines that can be used in assessing the compliance of a medical device with these principles.
ISO 18113-1: 2009 establishes general principles and essential requirements for the information provided by the manufacturer of in vitro diagnostic medical devices.
IEC standards
IEC 62304: 2006 specifies the lifecycle process for medical device software development.
IEC 62366-1: 2015 describes the process of analyzing, specifying, developing, and evaluating the usability of medical devices. It also describes the risk assessment and mitigation during proper use of the device.
IEC 82304-1: 2016 provides manufacturers with guidance on the safety and security of health software products designed to operate without dedicated hardware.
Compliance with standards such as ISO helps medical device manufacturers demonstrate the high level of quality and safety of their products, as well as manufacturers ’concern for the environment and consumer interests. If you want to enter the medical device market and have your device meet the required standards, the ScienceSoft healthcare IT team will be happy to help.
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