A thorough and robust risk management process is essential for the development of a safe and effective medical device. Team Consulting employs an independent risk management lead in each of your projects. This helps facilitate a multi-disciplinary approach and allows you to focus on the risks, not the documentation.
Risk management experts
Medical device regulations are constantly changing. Team has a dedicated risk manager so you don’t have to worry about staying up to date with industry best practice and regulatory requirements. Our risk manager makes sure we adopt a consistent approach across the company, working in compliance with ISO14971:2019.
Cost effective device development through risk management
Starting risk management early in the development of your product allows you to quickly identify and mitigate risks in your design, helping to avoid costly changes in the future.
At Team, we understand the importance of conducting an initial risk assessment on early concepts. Understanding risks can help inform your selection process and enable you to identify potential high-risk elements in your design that need to be addressed. These early risk assessments do not form part of the technical or design history file and can be conducted before creating a risk management plan, saving cost and speeding up time to market.
As we move through the development process, we:
Liaise with your team and key stakeholders to create a project-specific risk management plan. This can be based on Team’s risk management plan template, or one provided by you.
Support you in creating a hazard identification table to identify risks early on.
Facilitate use risk analysis.
Facilitate process risk analysis
Facilitate a bottom-up risk analysis such as design Failure Modes and
Effect Criticality Analysis (dFMECA).
Helping you navigate variances in dFMECA
There are variances in dFMECAs and in how they are implemented in different situations. For example:
A handheld drug delivery device which comprises up to 20 parts will require a different dFMECA approach compared to large medical devices comprising hundreds or thousands of parts.
There are also variances in dFMECAs across disciplines, such as mechanical, electronics and software. For example, you can predict the likelihood of a mechanical component breaking and use this to determine the overall risk, but when evaluating software we assume that all identified conditions will occur.
Team can help in various ways including standalone Risk Management (RM), gap analysis/expert review and risk management within a full medical device development. We have experience using many different tools in the risk management process:
Mechanical, Electronics and Software Risk Analysis, Hazard Identification,
Preliminary Hazard Analysis (PHA), Fault Tree Analysis (FTA), Failure Modes and Effects Criticality Analysis (FMECA)
Use Related Risk Analysis (URRA), Task Analysis, Perception, Cognition, Action Analysis (PCA)
Process Risk Analysis, Design for Assembly (DFA), Design for Manufacture (DFM)