How Medical Device OEMs Can Use ISO 14971 to Create a Risk Management Process

In the medical device industry, risk mitigation is non-negotiable. Device manufacturers are tasked with improving quality of life and keeping patients safe. Both are significant responsibilities.

ISO 14971 outlines principles for medical device OEMs to establish and apply a risk management process throughout a product life cycle, from inception to end of use.

Compliance with the standard is voluntary. However, medical device manufacturers throughout the world have adopted ISO 14971 as best practice for risk management. By following ISO 14971 compliance, OEMs ensure adherence to medical device safety standards that is recognized by many regulatory bodies — including the U.S. FDA — as a viable, auditable, risk management process.

Incorporating ISO 14971 principles into a risk management strategy requires understanding some of the standard’s key process points and the help of an experienced medical device consultant to fully realize the benefits.

ISO 14971 Process Overview

In the broadest sense, a risk management process is developed to identify hazards, assess risks, and establish control measures to monitor and mitigate medical device risk.

Within the parameters of the ISO 14971 standard, the steps and strategy around the process generally look like:

1. Build a risk management framework that includes detailed information regarding management roles and responsibilities, clear documentation of the risk management plan, and creating a risk management file for collecting records and other information produced during the risk management process.
2. Define the scope of the medical device and its intended use to keep the risk management strategy on target.
3. Identify any potential risks presented by the medical device.
4. Assess risk acceptability by using a risk acceptability matrix to plot where individual risks fall on the scale of potential harm severity and probability.
5. Implement and document risk controls as necessary, based on the results of risk acceptability and risk-benefit analysis.
6. Apply findings and feedback to refine the risk management plan and process.

Even when viewed at this basic level, managing medical device risk using ISO 14971 guidance can appear overwhelming, especially given its critical importance to patient safety and welfare.

Working with an experienced medical device consultant can bridge any gaps and alleviate concerns about risk management process setup and performance.

How a Medical Device Consultant Supports and Improves Risk Management

Medical device manufacturers often face competing priorities. Allocating team members and resources to achieve the many necessary business and project objectives is complicated enough. Add in nuanced processes like risk management, and unwanted delays and costs could arise.

Collaborating with an expert medical device consultant is a solution that offers many benefits. A single-source provider such as Kapstone Medical can tap into a multidisciplinary team to address ISO 14971-based risk management alongside or in place of a manufacturer’s internal team.

In addition, the years of experience with ISO standards and regulatory bodies a consultant brings to the partnership rounds out a risk management strategy by offering added value in:

• Developing and incorporating risk management procedures within a manufacturer’s quality management system (QMS) based on ISO 14971
• Assuming ownership of as much of the project as necessary to accommodate a manufacturer’s needs and support their team — streamlining time and costs
• Training manufacturer teams on risk management principles and processes
• Reviewing in-place or newly developed risk management processes for accuracy, documentation, risk-benefit analysis, or any other part of the strategy
• Providing ongoing support that encompasses post-production needs such as non-conformance and customer feedback evaluations, and other post-market surveillance monitoring activities

Mitigating any risk that could pose a threat to patient safety and welfare is job one for medical device manufacturers. Using ISO 14971 to guide risk management promotes a process that is proven, trusted, and sought after by regulatory bodies.

Likewise, turning to a single-source medical device consultant for support and guidance on creating robust strategies around all processes can put your team, product, and business at a decided advantage.

Learn how we can help you navigate the complexities of regulatory submissions in US FDA 510(k) From Concept to Clearance: A Guide for Medical Manufacturers. Click below to download your copy.