Written By: Rebecca Blice, Biomedical Engineer at Nottingham Spirk
Developing medical devices involves complexity typically not present when it comes to a consumer packaged good. The process is similar – Insights, design, engineering and testing – but the intensive documentation required for FDA approval is a key difference. Documenting all steps in the process and storing those records so that they can be easily accessed and reviewed is critical, both for efficiency of the process and for FDA compliance. The Quality System Regulations, 21 CFR Part 820, state: “Manufacturers must establish and follow quality systems to help ensure that their products consistently meet applicable requirements and specifications.”
The Benefits of eQMS Software
The regulations further state that “the responsibility for … having objective evidence of meeting these requirements may not be delegated even though the actual work may be delegated” (emphasis added). This is why Nottingham Spirk invested in a robust enterprise quality management system (eQMS) that stores all records in one location and provides for easy exporting of deliverables.
The software allows NS to:
- Model and manage the medical device design process
- Append files, information and evidence to the deliverables within each phase
- Conduct electronic phase review and approval when deliverables are completed in a phase
- Maintain all information along with the associated reviews and approvals online by project
- Define and maintain the electronic Design History File (DHF) online in real time
A DHF shows that a device was developed in a design control process that meets FDA requirements, which state: “Each manufacturer of any class III or class II device, and [certain] class I devices … shall establish and maintain procedures to control the design of the device in order to ensure that specified design requirements are met.” The DHF therefore must include all steps in the design review, verification, validation and transfer (into production specifications) processes, as well as design changes along the way.
3 Pillars of Design Compliance
Jama Software describes the DHF as one of three “pillars of design compliance for medical devices”:
Design Controls: The moving parts of product design and development
DHF: Collection of records from design and development activities
Device Master Record (DMR): The “recipe” for product manufacturing once design is complete
As the second pillar of design compliance, the DHF connects the first and the third pillars. As noted, it documents that the correct design control process was followed. The DHF is also the basis of the DMR, which must be created according to design specifications. An incomplete DHF makes it nearly impossible to prove you used the correct design control process for meeting FDA compliance, or create a compliant DMR.
Surprisingly, given the complexity of compiling a comprehensive DHF, not all companies involved in medical device product development are using an eQMS. “Believe it or not, the most common format for a DHF is still paper,” according to Jon Speer, founder and VP of software developer Greenlight Guru. In a paper-based system, it’s more difficult to create traceability matrices, which “represent a roadmap to what’s in your DHF and show the relationship from design control activities. The FDA inspector will appreciate the understanding of how everything works, but traceability matrices also are an important internal tool to keep team members on the same page.”
Small companies and start-ups that are working with design and engineering partners on medical devices need to ensure that those partners have the expertise and the tools necessary to document their work to the FDA’s standards. And if you’re doing it on your own, make sure to keep a robust history – either electronically or on paper – of the design process, or you may miss out on FDA approval.
Learn more about Nottingham Spirk's expertise with medical device design, as well as our innovation approach.
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