Background
Our customer, a medical device manufacturer, faced an industry-wide challenge: assemble isolated risk management activities into a comprehensive approach that made sense for the business.
With the help of Oriel STAT A MATRIX, this customer’s in-house team learned how to build a systematic, dynamic risk management process and risk management files.
Customer Challenge
Create a systematic risk management process and the needed documentation to comply with regulatory, ISO 14971, and ISO 13485:2016 requirements.
Our customer, like many companies, had risk management activities occurring in design, manufacturing, validation, CAPA, complaints, and other areas, but they did not have a comprehensive process that served the business or could be articulated to an auditor. In addition, the company’s risk management files were static – they were not being updated with post-production, post-market, and other relevant data.
Oriel STAT A MATRIX Approach
Oriel STAT A MATRIX combined formal classroom training with coaching to empower our customer to develop and improve their risk management process and risk management files.
The training established a common understanding of foundational risk management at the company. Oriel STAT A MATRIX delivered the three-day course Risk Management for Medical Devices: ISO 14971, which covers the process of risk management; regulatory and ISO 14971 risk requirements; how to identify, estimate, and minimize hazards and risks; risk management file requirements; and specific risk analysis tools and methods.
The Oriel STAT A MATRIX instructor also scheduled a time to be on-site at the company and shift into a coaching role. The coach guided the team through examining current activities, identifying areas to improve, and designing needed process changes.
Results
The customer’s in-house team learned how to create a systematic, dynamic risk management process and risk management files.
Oriel STAT A MATRIX prepared the customer’s in-house team to apply risk management methodologies and tools to build a systematic risk management process with defined inputs, tasks, outputs, and a feedback loop. This process included updating – according to pre-defined criteria – the risk management files to reflect post-production and post-market experience, clinical benefits, and other data.