A Guide to Medical Device Risk Management & ISO 14971

Medical device risk management is rightfully an essential component of medical product design and development. When it comes to putting a product on the market, risk analysis is required by law, and regulation checklists must be followed thoroughly. These regulations are carefully outlined in ISO 14971 to ensure all medical devices are safe before reaching users.

Why Is Risk Management So Important for Medical Devices?

Medical devices are meant to help people and improve patient outcomes. If the product isn’t safe and effective, however, it could end up causing serious harm to the user. That’s why risk management is critical to every phase of a medical device project, no matter if you’re designing a new revolutionary product or making small changes to an existing one. Rigorous commitment to medical device risk analysis not only helps ensure a safe and quality product, but is an important step on the path to gaining regulatory approval.

Not being diligent about managing risk can also negatively impact budget and time to market. Without following a proper risk management process, you could end up with a project lacking certain mitigations that could affect your ability to get approval and require you to go back through the design and development process.

Understanding the Role of ISO 14971

ISO 14971 is the application of risk management to medical devices. It outlines the process device manufacturers should follow, from medical device risk analysis, evaluation, and mitigations to residual risk analysis and management. These standards are in place to ensure products are appropriately safe.

ISO 14971 outlines 10 basic steps to perform proper medical device risk management protocols.

1. Establish a risk management framework
-Define your process
-Delegate roles and responsibilities
-Document your plan
-Create a living risk management file

2. Specify intended use
-Define the scope of the device and document its intended use(s)

3. Identify any hazards
-Document potential sources of harm that could result from improper use or product malfunction

4. Define hazardous situations and foreseeable events
-Estimate the level of risk involved with each hazard

5. Estimate risk
-Assess the probability of harm occurring and its severity

6. Evaluate risks
-Determine if estimated risk levels are acceptable or if risk reduction is required

7. Perform risk control
-Reduce risks to acceptable levels

8. Evaluate overall risk acceptability
-Determine if you have reached an acceptable level of risk
-Identify if benefits outweigh potential risks

9. Review risk management
-Review your process
-Create a risk management report prior to production

10. Collect production and post-production information
-Perform and analyze internal audits, CAPAs, complaints, customer feedback, and non-conforming materials to improve your risk management process

Read the most recent ISO standards.

Our Medical Device Risk Management Process

Risk management is inherent to Gilero’s process for medical device development. As part of our quality management system (QMS), we have numerous procedures, work instructions, and forms in place to help manage risk at every level of our organization. A few areas of emphasis within our process include:

• Maintaining an effective and current QMS that thoroughly evaluates both quality control and assurance
• Training employees to quality standards from that QMS (i.e. what to do if a device causes an adverse event, keeping track of project documentation, when and how to file appropriate regulatory documentation, etc.)
• Training employees on how to correctly perform tasks and safely operate equipment (i.e. how to prepare for entering the cleanroom, wearing safety goggles and other protective gear when working with certain machinery, etc.)

To help ensure medical and drug delivery devices are properly evaluated, Gilero provides a range of testing services, from early proof of concept testing to final design verification and validation. Gilero can execute most types of medical device testing in our onsite test labs. To learn more about how we can help ensure your medical device is safe and effective, contact us today.