The video explains more about the cleanroom facility that is available FREE of charge to help in the battle against Covid-19. Please share so this message gets to the people who could make use of this facility.
Do you have an idea for a new medical device and want to know how much it will cost to get it from where you are now to the point that it is regulatory approved and ready for commercialisation? Do you also want to know the steps involved and the timescale that is likely to … How Much Will It Cost to Commercialise Your Idea for a New Medical Device?
The coronavirus threat is difficult for everyone, and it’s fast-evolving. At Arrotek, we have taken steps to protect our employees as well as our customers and others. This includes following the advice provided by national and international bodies. As a result, we have begun a programme of working from home, with many members of the … Arrotek’s Response to the Challenges of the Coronavirus
As we in Arrotek endeavour to support the measures to tackle the COVID-19 situation, one aspect that has been identified is a possible lack of cleanroom space. As I`m sure you all know, Arrotek Medical recently moved into a new facility in Sligo. The previous facility is currently empty and available. This is a facility … COVID-19 Support message 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 … 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
