Arrotek

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

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

Design verification and design validation are essential parts of the medical device product development process. Sometimes referred to as V&V, it’s important to understand what both terms mean and how they differ if you are about to embark on a medical device product development project. This is because V&V can take more time than necessary … Medical Device Design Verification and Design Validation – What They Are and Why They Are Important