Any device used for medical purposes. Most commonly these are instruments, machines, implants or in vitro reagents, that are intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in humans or other animals.
The wide breadth and depth of medical devices can be organized into three classes based on their importance in human survival. Class I are low-risk devices (e.g., bandages, laryngoscopes, and endoscopes). Class II devices are intermediate-risk devices (e.g., computed tomography (CT) scanners or infusion pumps for intravenous medications). Lastly, class III devices are high-risk devices that are essential to health or sustaining life (e.g., pacemakers and deep-brain stimulators). Additionally, the International Standards Organization (ISO) classifies these devices based on their patient contacting categories and surfaces (1).
Medical devices have an extensive reach across the healthcare industry and beyond. Medical devices require research and development (R&D) engineers for design, manufacturers for production, consultants for validation and quality assurance, and physicians for use. As MicroBio consultants were work hard to ensure the smooth and successful validation of medical devices as they enter intra- and international markets.
Depending on where a medical device is in its lifecycle, they are developed and used in research laboratories, testing facilities, and hospitals. The extensive reach of medical devices means they exist globally in established medical care systems.
Medical devices require extensive innovation and re-design. Re-design is often the result of remediations to medical devices, updates to ISO and FDA standards, and accommodations for newer versions of the Instructions for Use (IFUs). Since the creation of hypodermic syringes in 1853, which lacked even a glass piston to prevent leaking and infection, medical devices have come a long way in their design, and now include safety features, such as a plastic piston in hypodermic syringes. Moreover, today’s medical devices are made from various materials, including, but not limited to, metals, plastic polymers, and ceramics (2).
The process of medical device design and its material selection requires detailed engineering and biological skills to understand both the sustainability and the in vivo effects of medical devices (biocompatibility). Following the design process, standard testing procedures (e.g., tensile, wear, and oxidation testing) are performed to measure the product's safety. Subsequently, MicroBio consultants are educationally experienced and trained to thoroughly understand the standards set forth by the Food and Drug Administration (FDA) and ISO in order to review products and their respective in vitro tests to assess their safety and efficacy in patient care. Lastly, the product can now be manufactured. Manufacturing is a standard process of producing the product in mass to distribute to hospitals, physicians, patients, and the general public. For a free consultation about how MicroBio Consulting can help you classify and approve your medical device contact us today!
and ISO 13483