A medical device is any device intended to benefit patients by helping health care providers diagnose and treat patients and helping patients overcome sickness or disease, improving their quality of life. In the US, the FDA recognizes 3 classes of devices categorized on the level of control necessary to assure safety and effectiveness. Class I devices are those that pose the least risk to the patient and are subject to the least amount of regulatory scrutiny. Class II devices pose a moderate to high risk to the patient and require special controls. Class III devices pose the highest risk to the patient and support or sustain life, are implanted, or have a high risk of injury or illness.
As such, the general rule is that the higher the risk, the greater the amount of testing is required to assure the safety and efficacy of the device. Along with the increased risk comes additional regulatory filing, ranging from a simple 510k to a Premarket Approval Application. Raland medical device regulatory professionals have the knowledge and experience to navigate the submission filing process.
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Many countries have similar classifications for medical devices but, to varying degrees, different approval processes. As an example, in the EU, the new Medical Devices Regulation (EU MDR) is well underway. Many manufacturers have yet to complete the required certification and may be at risk of losing their CE Mark and access to the EU market.
Medical device companies have been under intense scrutiny by the FDA for over 10 years with a major focus being on the presence of, and adherence to, a corporate Quality System commensurate with the complexity of their device and manufacturing processes and the size and complexity of their manufacturing facility. Raland medical device professionals have the knowledge and experience to assess a client’s Quality System and identify opportunities for improvement to limit the risk of future enforcement action.
Click here to see the full range of medical device support services we offer.