RISK MANAGEMENT
At Hands on Research, we understand that effective risk management is central to demonstrating the safety and performance of medical devices throughout their lifecycle. Our services help manufacturers identify, evaluate, control, and monitor risks in line with regulatory expectations, including the requirements of the EU MDR and ISO 14971, the international standard for medical device risk management.
We work with you to develop and maintain risk management documentation that is proportionate to your device, aligned with your clinical evaluation and post-market surveillance activities, and suitable for regulatory review. Our support includes evaluating risk management activities across key device-specific areas, including usability, software, cybersecurity, biological safety, and electrical safety, ensuring these considerations are appropriately documented and connected to the wider risk management file.
We do not treat risk management as a standalone document. Instead, we help ensure that your risk management file is connected to your device’s clinical evidence, intended purpose, claims, usability considerations, PMS findings, PMCF activities, complaints, vigilance data, and overall benefit-risk profile.
Whether you need support creating a new risk management file, reviewing existing documentation, or strengthening the links between risk, clinical evidence, PMS, PMCF, and benefit-risk conclusions, our team can provide practical, tailored support.
Our approach is collaborative, thorough, and focused on helping you demonstrate that risks are appropriately managed and that your device remains safe and effective for users and its intended uses.
What we offer
ISO 14971 implementation
We create and review risk management files that are audit-ready, proportionate to the device, and aligned with the wider technical documentation.
Our work covers a broad range of product types and risk profiles, including higher-risk devices, active devices, software-containing products, and technologies where cybersecurity, usability, or complex system interactions need to be considered as part of the risk management process.
Clinical evaluation alignment
We check that your risks, benefits, clinical claims, CER conclusions, PMS activities, and PMCF plans are consistent and support one another.
This helps avoid gaps between the clinical, technical, and regulatory parts of the file, especially where the device includes software, active functionality, novel features, cybersecurity considerations, or claims that need careful justification.
Benefit-risk assessment
We help you build clear benefit-risk assessments that connect the device’s intended purpose, clinical evidence, known and foreseeable risks, residual risks, and overall regulatory rationale.
This is particularly important for complex or higher-risk products, where the benefit-risk position needs to be easy to follow across the technical file, clinical evaluation, PMS outputs, and submission documentation.
Regulatory readiness
We prepare and review documentation for EU MDR, UKCA, FDA, notified body reviews, audits, and technical file submissions.
Where needed, we also help bridge the gap between technical and regulatory teams, so that submission decisions are clear, evidence is presented in the right place, and the rationale behind the chosen pathway is easy for reviewers to understand.
Our team of experts provide clear, connected risk management for safer medical devices.
If your risk management file needs creating, reviewing, or strengthening ahead of regulatory submission, we can help you build clear, connected documentation that supports your device’s safety, performance and benefit-risk position. Book a free 30-min consultation and receive practical ISO 14971 risk management support tailored to your device, your evidence base and your regulatory pathway.