Clearing the ISO 14971 risk management standard can be a pain without the right tools in place.
One of the most difficult challenges to hurdle is 14971 because it is the perfect storm of complex and vague. The last thing you want is to have to battle a cumbersome enterprise Quality Management System (eQMS) software while trying to stay compliant with ISO.
One thing is clear — you need to make sure your software is designed to help you instead of holding you back.
We'll show you why it's important to find an eQMS which is built for ISO 14971 risk management and how you can know if the one you have now or a future system meets your needs.
Is Your eQMS Built for ISO 14971 Risk Management Compliance?
ISO 14971:2007 outlines the process that a manufacturer must follow to identify the hazards associated with medical devices, including in vitro diagnostic (IVD) devices. This standard specifies how to estimate, evaluate, and control risk as well as how to monitor your controls for effectiveness across all stages of the lifecycle.
The FDA and EU Competent Authorities want risk management activities to be a part of your overall design and manufacturing process. While this might seem like a burden initially, it actually helps you build higher-quality products and run your business more smoothly.
You need to get your systems and processes in place to make managing risk easier throughout the product lifecycle. Our eQMS is built to help medical device companies with 5-500 employees manage compliance with regulations like ISO 14971 with ease.
But, whether you choose Qualio as your cloud-based solution or not, don't settle for a provider who delivers less than everything you need for 14971 compliance. Let's take a look at the features that you should look for when evaluating the best eQMS software solutions.
1. Flexibility in Risk Management Documentation
The right eQMS software will be flexible enough to adapt to your needs and not limit you into one specific format. Your risk management files will look different from product to product and document to document. If you are limited to only one "format" that would hold you back instead of propelling you forward.
2. Ability to Document Your Overall Process
You should have a clearly defined document management process in place for your company — and that includes how you manage your risk assessment documentation. You should be able to easily analyze, manage, and control all of your documentation from initial concept through to post-production information related to your device and its manufacturing.
3. Clear Visibility for Management
Your management team is in place for a reason. They are experienced and trustworthy people that are helping to provide crucial oversight and input throughout each stage. The eQMS system that you select should have mechanisms in place for allowing the right people to review risk management documentation and progress as well as approve or comment on files.
4. Employee Training Records
It takes more than just purchasing software to make it work successfully for your needs. You need to have a team of employees that is dedicated to the success of the system and your company. They need to be trained on how to use the risk management aspects of your system and you need to be able to document their training.
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5. Documented Risk Management Plans
You should have well-documented risk management plans in place that includes planned activities related to ISO 14971 risk management, assignment of responsibilities and authorities, review requirements, criteria for risk acceptability, and all activities related to collecting and reviewing information throughout the production and post-production lifecycle.
6. Documentation Related to Risk Analysis Processes
Your overall risk analysis process must be thoroughly documented. You should have records of which person is carrying out the risk analysis, the scope and date of their analysis, and a description and identification of the design associated with the risks.
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7. Risk Management Review Prior to Release
Part 8 of the ISO 14971 specification requires you to carry out a risk management review and prepare a risk management report before your medical device can be released to the market. You need to be able to track how well your plan was implemented, if remaining risk is acceptable, and that you have appropriate methods in place to be able to gather all relevant production and post-production information.
8. Easy Access to Support for Setup
When you're initially configuring your risk management procedures in your software, you'll want to make sure that you aren't wasting time fighting the system to get things in place before you can use it. Find out what kind of support or onboarding systems that your eQMS system will provide to help you get started quickly.
9. Ongoing Support
After you begin using the system, you don't want to run into delays just because you can't figure out how to execute a specific component inside the software. Make sure that your contract with your eQMS provider includes access to support personnel when they are needed.
The customer service is outstanding! I like that with their coverage in spanning time zones, we have full support at almost any hour of the day; your question does not sit in a queue rather they have support on the ready to help you with any question or need you may have. — G2 Reviewer
More Considerations for a Fantastic eQMS
A quality eQMS software will help you achieve full transparency across your product lifecycle so you can get to market faster, produce higher quality products, and earn higher revenue.
In the life sciences industry, speed-to-market can be one of your most important competitive advantages. Making the right choice in your eQMS software elevates you above your competitors by streamlining your compliance and enabling you to operate in a 24/7/365 audit-ready state.
Avoid the pain of buyer's remorse by downloading our guide filled with 12 Questions to Ask Before You Buy an eQMS.