Document organization tips for medical device designers

 In Medical Product Design

No matter what industry your line of work falls under, keeping documentation in order is vital. For medical device designers, organizing specific details in regard to design, development and manufacturing, as well as the information on FDA compliance and regulations is a critical part of the creation process. Without this documentation to fall back on, you don't have proof that you're practicing compliant document management standards, which could tarnish your reputation as a designer – and keep you from moving forward with your product.

Furthermore, unless you have immediate access to critical details in your design and development process, problems can occur with the manufacturer that keep your medical device from meeting FDA compliance.

The truth is, you should be treating this important documentation just as you would your medical device design, prototype and final product. When done the right way, an organizational strategy can improve regulatory standards, increase security and take the burden off of worrying about lost information.

To ensure everything stays in order, consider the following organizational tips:

1. Come up with a management strategy
Before you can get serious about organizing documents, you need to come up with a smart management strategy. First, Quality Digest recommended mapping out all of the different records that will be created during the device production process. Keep tabs on all quality management system activities you perform and file this information away, and make sure data related to design and risk management is made accessible to your team members, suppliers and the FDA. Other vital information you need to keep track of includes device history records, complaints and customer feedback, corrective actions made, non conformances and order changes.

Come up with a strategy for organization.Come up with a strategy for organization.

2. Invest in digital management software
Next, you need to plan for scalability and flexibility. That means making your records and files accessible to anyone who works in close quarters. The easiest way to do this is by investing in digital management software. While you might be comfortable using a paper-based documentation system, it will only cause problems in the long-run. Find an electronic database with features that make it easy for the user to store and maintain information. Not only will this take the burden off of filing physical pieces documents, but it can bring down your margins in paper costs as well.  

3. Keep up with organization
Creating a digital management strategy shouldn't be a one-time deal, rather, you need to prioritize maintenance. Organizing your documents on a regular basis ensures that all information is easily accessible no matter what. This will save you time and worry in the event of an audit by the FDA – which can happen without notice, as stated by MedCity News. Plus, you don't want to let all of that time and effort spent creating your organization strategy go do waste, do you?

4. Grant file access to your team
To ensure your entire team is on the same page – and that nothing falls through the cracks when you're not around – grant everyone access to the organized database. Anyone who is helping you design and develop your next medical device should be able to take notes and file information based on changes and solutions that could ultimately impact the final outcome. Make sure you hire a trusted team of individuals before granting access to this important information.

These tips should be considered before your start developing your initial design, but shouldn't be ignored if you're already halfway through the process. Organization can be your saving grace in the event that an important detail gets lost in translation.


Recent Posts