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 ELIQUENT (formerly 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.
ELIQUENT Approach
ELIQUENT 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. ELIQUENT 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 ELIQUENT 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.
ELIQUENT 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.