News from Arrotek

In medical device design projects, there are both product risks and project risks. Product risks are talked about a lot as they are about the safety and effectiveness of the product. Managing product risks is also an essential part of the regulatory approval process. From a commercial perspective, project risks are critical too. Therefore, it’s also important to manage project risks when designing a new medical device. Product Risk Management vs Project Risk Management Product risk management is about product safety and ensuring the product does what it is expected to do. There are well-document guidelines, standards, and requirements you...

Issues surrounding the implementation of the European Union’s new Medical Device Regulations (MDR) are a hot topic of conversation right now in the medical device industry. After all, that implementation starts in May of this year while today, significant challenges exist. Those challenges include the availability of MDR-designated Notified Bodies, the high workloads currently being experienced by those Notified Bodies, the uncertainty around grace periods, and the availability of EU-published guidance. These issues are now well-known and they are discussed and debated regularly. For example, they are scheduled to be key discussion points at the MedTech Live event taking place...

There are key questions you need to ask about your new medical device idea as part of the process of getting approval from regulators in the markets you plan to launch in. Our animation outlines the key compliance questions you will need to answer. Watch now: https://youtu.be/uRxkxkdDONY  

When you design and develop a new medical device product, you must establish, manage, and enforce standard operating procedures, otherwise known as SOPs. What are SOPs, though, why do you need them, when do you need them, and what do you need to do? Before getting into those questions, let's look first at why SOPs are important even when you are at the early stages of developing your concept for a new medical device. Having SOPs in place and enforcing them is a requirement of regulators around the world, including in Europe and the US. More specifically, SOPs are part...

At Arrotek, we are an engineering services provider specialising in the medical device industry. Our specific focus is on single use medical devices. Watch our new video to find out more about how we can help design, develop, get regulatory approval for, and/or manufacture your MedTech product. https://youtu.be/uMZlgu94aMs

There are a number of steps that need to be taken in relation to risk management when designing a new medical device. This includes identifying hazards and hazardous situations. You then need to evaluate the hazards and hazardous situations you identify before, potentially, putting control/mitigation measures in place and then monitoring those controls. The second stage of the above process, evaluating hazards and hazardous situations, involves estimating two essential factors: The probability of occurrence The severity of harm By combining these two estimations together you will be able to define the risk as being either acceptable or unacceptable. This definition...