Risk management is central to ensuring the safety, quality, and efficacy of products in the healthcare sector. Two of the most prominent frameworks in this domain are ISO 14971 for medical devices and ICH Q9 for pharmaceuticals. While both aim to manage risks to patients, users, and the environment, they arise from different regulatory and…
Introduction: What Are Human Factors Human Factors (HF), also known as ergonomics, is the scientific discipline concerned with understanding interactions among humans and other elements of a system. In healthcare, this translates to how patients, caregivers, and clinicians interact with medical devices, digital tools, and combination products. The goal is to design systems that…
The regulatory landscape for medical devices, in-vitro diagnostics (IVDs), and other healthcare technologies is evolving rapidly in 2025. These changes aim to enhance safety, sustainability, and innovation while ensuring businesses comply effectively with new requirements. This blog will walk you through key developments, including updated EU regulations on medical devices, batteries, AI, packaging, and substance…
Combination products integrating drugs, biologics, and medical devices offer significant advancements in treatment efficacy and patient compliance. As self-administration and home based therapies become more prevalent, manufacturers must navigate a complex regulatory landscape to ensure product safety, usability, and compliance. This article explores key considerations in designing combination products, including platform device strategies, risk based…
In the intricate space where drugs, devices, and biologics intersect, the resulting products are known as combination products. This segment of the medical device and pharmaceutical industry is thriving. However, the path to developing, manufacturing, and marketing these products is fraught with complex regulatory requirements and operational challenges that demand meticulous attention to detail. For…
Upon completion of the risk assessment, a comprehensive benefit-risk analysis is carried out. This vital step establishes the acceptability of product risk, carefully weighing the potential benefits against the identified risks. All of these critical measures culminate in the creation of a detailed risk management report, effectively summarizing the full range of risk management activities…
After determining the scope of the product risk management activities and documenting them in the Risk Management Plan, now the actual risk assessment can begin. In this article, we look at the various elements of what goes into a risk assessment for a product and how to determine the overall acceptability of the risks for…
When performing risk management activities for a medical device, those activities shall be planned according to the ISO 14971 risk management standard. The risk management process, if conforming to the standard, should include provisions for creating a Risk Management Plan to guide and govern the various steps involved in assessing the risk of the product….
If you’re designing, marketing, or selling a medical device, you’re surely familiar with the fact that risk management is an ever increasingly important regulatory requirement and topic. The international ISO standard for risk management is 14971:2019; with few exceptions, regulating bodies worldwide recognize ISO 14971 as the requirement for a risk management process that will…
