Errors in design control can cause major issues for medical device companies. In fact, according to recent reports, the leading causes of product recall are device design and product control issues. Believe it or not, the number of product recalls jumped to an astounding 71% in 2019.
So what does this all mean for your medical device company?
Because the stakes are so high, you can't afford to start design control from scratch.
Pick from one of these five medical device design control templates to speed up your design process and ensure smooth sailing through regulatory compliance.
5 Medical Device Design Control Templates Available for Download
Design control templates can be a great place to start if you don't have these documents in place already. A QMS created from templates can be sufficient for FDA and EU MDR audits, but it’s easier to make critical mistakes with this approach.
We recommend you only use the templates suggested below as a starting point. You should upgrade to an eQMS, such as Qualio, and start customizing these templates as soon as you are able. The longer you wait, the harder and more complicated it will be to change your processes to better suit your specific requirements.
Qualio was built with medical device manufacturers in mind, so it has all the tools a startup or young company requires. Plus, our expert team has helped hundreds of life sciences companies just like yours transition from inefficient paper-based systems to our eQMS.
Without further ado, here are the five templates you may want to check out.
Cockpit provides a template for design controls that help you meet the FDA’s best practice standards outlined in 21 CFR 820.30. Not all medical devices are required to adhere to the Design Control standards, so make sure to read through 21 CFR 820.30 to find out if you have to comply
Cockpit’s template provides fields for design and development planning, design input, design output, design review, design verification, design validation, design transfer, design changes, and design history files.
They even include electronic signatures so you can ensure you’re Part 11 compliant, and test results are stored in their database by using UI commands.
Trace tables that show connections between tests, design inputs, and design outputs are auto-populated and can be exported to a Word, PDF, or Excel document for submission to the FDA.
2. Medical Device Academy
The Medical Device Academy has a template for device testing and one for design and risk management. Their comprehensive templates can be helpful with maintaining compliance, but they even caution on their website that it does not include everything.
You need to manage your projects efficiently and ensure that you don’t forget to perform any required testing. Failure to perform the necessary tests may result in your device taking much longer to get to market.
You need to accelerate your processes so you can get your products to market as fast as possible. Using an eQMS such as Qualio is a much better solution if you want to speed up product development and testing while maintaining compliance.
3. Alvin Tai
Creating procedures for developing and maintaining a quality system is time-consuming, and it’s easy to make costly mistakes that lead to compliance issues.
Alvin Tai wanted to help companies comply with FDA and ISO standards, so he started releasing free Design Control Procedure templates. His Design Control SOP template was created with ISO 13485 standards FDA and CFR 820 regulations in mind, and it is geared toward medical device companies like yours.
Qualio simplifies the process by providing you with an all-in-one solution. You won’t have to find and download multiple templates for every step of the product development process—enabling you to bring products to market faster.
4. GMP Labeling
GMP Labeling offers several templates for SOP medical device design and document controls. Their templates are not free, and the prices vary.
Some of the templates they offer include:
- Group MD200 Design and Document Controls SOP
- MD20 Design Controls SOP
- MD21 Device Master Record SOP
- Document and Change Controls SOP
- MD23 Risk Management SOP
- MD24 Control of Records SOP
- MD25 Good Documentation Practices SOP
- MD25 Design History File SOP
You can find all of these templates available for purchase on their website.
MedicalDeviceHQ is similar to GMP Labeling. They have several templates available for free, and some you have to purchase.
The templates they offer include:
- Risk Management Plan Template (Medical Device and ISO 14971)
- Risk Analysis Hazard Traceability Matrix
- Design and Development Plan Template (Medical Device per ISO 13485 and 21 CFR 820)
- Status Report
- Checklist ISO 14971:2007 to ISO 14971:2019
- Risk Management Plan Template
- Project Charter Templates
- Standard Operating Procedure (SOP) for Risk Management According to EN ISO 14971
You can access all these templates on their website.
Why You Should Use an eQMS Software Instead of Templates
While a template-based QMS can be a lifesaver in a pinch for a company with limited funds, it’s not a permanent solution that we recommend using.
You can quickly become overwhelmed in a sea of disconnected and unorganized templates, and even the FDA recommends purchasing eQMS software for medical device manufacturers.
Qualio helps provide you with the structure you need to remain compliant—and the flexibility required for you to adapt to regulations and grow. Our software is cloud-based, so your employees can use it when they're on the go.
We are so confident that Qualio will meet all your needs that we created a free guide to teach you what you need to know in order to make an informed decision on which software provider to choose. Download your free copy of our guide now: 12 Questions to Ask Before You Buy an eQMS.