Knowledge Hub

Managing Medical Device Design Project Risks

by Mark Pugh
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...

New European MDR – Key Steps to Take at a Time of Uncertainty

by Arrotek
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...

Medical Device Product Compliance – Key Questions to Ask

by Arrotek
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:  

An Introduction to Standard Operating Procedures

by Arrotek
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...

Estimating the Probability of Occurrence and Severity of Harm When Assessing Medical Device Risks

by Ger O'Carroll
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...

Medical Device Risk Management Plan – What You Need to Know

by Ger O'Carroll
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 of carrying out a risk analysis at various points during the design of your medical device. This is an action that is part of risk management. Instead, risk management is a process and, for that process to be effective, documented, and transparent, you need a...

An Overview of Risk Management in Medical Device Product Design

by Ger O'Carroll
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 the processes and steps required to ensure the proper management of risk, this is part of the Quality System that you need to have in place when designing a medical device product. In addition to risk management, a Quality System includes management controls, document control,...

Medical Device Design Verification and Design Validation – What They Are and Why They Are Important

by Ger O'Carroll
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 if proper design controls are not put in place in the early stages of the design process. In other words, both design verification and design validation are made easier if you have well-documented user needs, design inputs, design outputs, and outcomes from design reviews. What...

Documenting User Needs – Key Questions You Need to Answer

by Ger O'Carroll
In a previous article, we outlined the importance of identifying and documenting user needs when designing a new medical device product. In that article, we looked at the two objectives you must achieve when documenting user needs: Defining the intended use of your new medical device product Defining the indication for use of your medical device product This sounds straightforward enough but when you go through it in practice, the process can be quite tricky, not least because documenting it is a regulatory requirement. So, how do you create the above definitions to complete the process of documenting user needs?...