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 … Managing Medical Device Design Project Risks
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 … New European MDR – Key Steps to Take at a Time of Uncertainty
2024 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:
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 … An Introduction to Standard Operating Procedures
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.
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 … Estimating the Probability of Occurrence and Severity of Harm When Assessing Medical Device Risks
This year Arrotek took part in the Spirit of Christmas Gift Appeal by buying a gift for a resident of Nazareth House nursing home in Sligo. It was a small offering, but very much appreciated by the residents of Nazareth house and brightened up what can be a lonely time of year for some of … Arrotek’s Spirit of Christmas!!
Arrotek were delighted to sponsor a prize for the Innisfree Athletics Club 5K Christmas Cracker last month. Congratulations to all involved!
As we have covered in a previous blog, risk management is essential when designing and developing a new medical device product. An important part of this process involves creating and maintaining a risk management plan. Before going any further, it’s helpful to define risk management. What is risk management? Risk management is not the act … Medical Device Risk Management Plan – What You Need to Know
Risk management is an essential part of the medical device product design process. It ensures the safety of patients, users, and operators so it’s no surprise that risk management is a regulatory requirement. Risk management is also essential to the medical and commercial success of the new product you plan to develop. In terms of … An Overview of Risk Management in Medical Device Product Design
