In the rapidly changing world of medical devices, most people are familiar with the term quality assurance. But did you know that a key facet of achieving good quality results lies in understanding and using the equipment correctly? As medical devices grow in complexity and become increasingly interconnected, proper training and the understanding of quality regulations becomes all the more important.
What is medical device training?
As the FDA defines it, a medical device is “an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is:
- intended for use in the diagnosis of a disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or
- intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes.”
With the evolution of equipment and digitization of technology, even diagnostic software is now being classified as a medical device which makes it subject to the same regulations and guidelines that pertain to other medical devices.
Now that we have defined what medical devices are, let’s understand more about clinical device trials. In the context of medical devices, a clinical trial or a clinical investigation is defined as a systematic investigation or study conducted on human subjects. Such trials are undertaken to assess the safety or performance and understand the risks of that medical device.
The regulations
According to the Medical Device Regulations (MDR) which was released in June 2017, manufacturers need to carry out a conformity assessment in order to demonstrate that a particular medical device meets the requirements stated in the MDR. The basis of the assessment route depends on how the device is classified.
These classifications are the foundation of the ethical and safety regulation for medical device trials. In order to successfully bring a medical device to market and ensure the accuracy of data and patient safety, it is essential to comply with these regulations.
Here are some common terms you may have heard of in this regard and what they imply:
- ISO 14155:2011
This international standard addresses good clinical practice for the design, conduct recording as well as reporting of clinical assessments carried out on human subjects in order to assess the safety or performance of medical devices for the purpose of regulation. - The CE marking process
When manufacturers place a CE mark on their product, it indicates that the medical device has passed the conformity assessment and has met all requirements. - FDA pre-market approval (PMA)
The FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices is known as pre-market approval. Those devices which support or sustain human life, and are of substantial importance in the prevention of human death, or a potential, unreasonable risk of illness or injury are known as Class III devices. - ISO 13485:2016
This international standard highlights requirements for a quality management system wherein an organization needs to continually demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.
Why we need device training
Simply put, the process of manufacturing medical devices is extremely high-risk and anyone involved in the making of such devices, as well as clinical trials, needs to understand what these regulations imply as well as their impact on the final outcome.
Failure to have current, in-depth knowledge and understanding of the regulations and processes concerned with the manufacture and testing of medical devices risks non-compliance and can ultimately lead to the inability of the medical device being to enter the market.
Quite naturally, with the evolution of technology, these regulations too have changed with time – with the most recent Medical Device Regulations coming out in 2017. For those who have undertaken training prior to this date, it’s highly advised to undergo additional training to remain current and compliant with the more recent guidelines. Remember, it’s always best to be proactive in such matters.