One of the most common misunderstandings in the medical industry is the technique the several national regulatory systems use to recognize standards. Here, in this post, you will understand the method, starting with standards from the International Organization for Standardization adopted as well as recognize in several regulatory systems.
Taking about medical devices, they are subject to strict controls and procedural regulations. The development and use of medical device standards are highly important to ensure the safety and efficiency of medical devices. Several regulatory agencies and standards organizations work together to start the accepted standards for medical equipment. Here, standard-setting activities include the development of performance features, testing methodologies, product standards, manufacturing practices, scientific protocols, ingredient specifications, compliance criteria, labeling, or other policy criteria.
The regulatory agencies and standards organizations start the standards and supervise compliance with standards, including
• FDA (The U.S. Food and Drug Administration)
• CDRH (The FDA’s Center for Devices and Radiological Health)
• JC (Joint Commission on Accreditation of Health Care Organizations)
• CLIA (Clinical Laboratory Improvement Amendments)
• CAP (College of American Pathologists)
• ISO (The International Organization of Standardization)
• IEC (International Electrotechnical Commission)
• The American Society for Testing and Materials (ASTM) International
Different types of devices determine the agency or agencies to whose regulation it is subject. You can conduct research to determine which regulatory agency is suitable for your type of device, as well as which standards are applicable. Medical devices include in vitro diagnostic products, including general-purpose lab equipment, reagents, test kits, and so on. In addition, several electronic radiation-emitting products, along with medical applications and claims, meet the definition of the medical device. Some of the examples are diagnostic ultrasound products, x-ray machines, and medical lasers.
Knowledge of standards recognized by the FDA is highly important if you want to get your device approved for sale in the U.S.A. The FDA department believes that conformance with the known agreement can support assurance of safety and effectiveness for several applicable aspects of medical devices. Hence, information added on conformance with several standards should have a direct bearing on safety as well as efficiency purposes made during the review of IDEs, HDEs, PMAs, and PDPs.
Examples of standard organizations which develop standards for Medical Devices
International Organization for Standardization: A non-governmental organization develops as well as publishes international standards on various subjects, including medical products. Medical-grade silicone manufacturers like SMI Manufacturing follow ISO standards for the production of their silicone medical devices. For the consumer, it ensures that products, as well as services, are reliable, safe, and high-quality. For business, they are strategic tools that can minimize costs by eliminating waste and errors and increasing productivity. These standards are relevant for medical devices as well as encompass every aspect of device design and implementation right from device inspection needs to guidelines for medical device labels.
International Electrotechnical Commission (IEC): A non-governmental organization prepares and publishes International Standards for all electrical, electronic, and related technologies. It utilizes more than 10,000 experts from industry, commerce, government, test and research labs, and academia and consumer groups. It cooperates with ISO to ensure that International Standards are congruent.
ASTM International: An internationally recognized leader in the development as well as delivery of international voluntary consensus standards. It utilizes more than 30,000 technical professionals as well business professionals from around 150 countries to develop standards targeted to support the protection and sustainability of the environment, supports public health and safety, contributes to the reliability of materials, products, services, and systems, and facilitate all levels of commerce. In the present era, it offers 12,000 standards which include various science and engineering disciplines that include biomedical engineering.