In the intense world of medical device startups, the importance of a robust quality system often takes a backseat to activities perceived as adding more immediate value and meaning. However, neglecting a quality system (QS) until after development is complete and the product is launched can be a costly oversight.
Medical device startups should approach the development of a quality management system (QMS) with the same dedication as they do when designing a medical device. Think of it as bootstrapping your QMS, building it incrementally as you progress. Align the structure of your QMS with the product and company milestones. For example, if you are in an early stage of product development, establishing QMS elements applicable for production and post-production may not be the best use of time. Instead, concentrate your efforts on creating a QMS for the processes relevant to the milestone you are working on.
Keeping it simple
Simplicity is key when it comes to your QMS. It must, of course, align with FDA and ISO 13485 regulations and requirements, but keep these three considerations in mind when crafting QMS procedures:
- Does it meet regulatory requirements?
- Is it as straightforward as possible?
- How does this impact the business?
Starting your QMS early and maintaining simplicity will significantly benefit your company. An early QMS setup ensures that your organisation generates the necessary documentation and objective evidence required during an FDA inspection or ISO audit.
Design to fit
Your QMS should be tailored to fit your company’s size. While QMS procedures must comply with FDA and ISO requirements, they should also not be overly burdensome or complicated to follow. The QMS should evolve in tandem with your company’s growth, personnel, and maturity.
Creating a comprehensive QMS in line with FDA and ISO 13485 standards can be time-consuming, and some may perceive it as adding minimal value to a medical device startup. However, understanding the QS requirements reveals that the majority of FDA Quality System (QS) Regulation (21 CFR Part 820) and ISO 13485 requirements focus on processes and procedures post-product development.
Four key steps to follow
As a medical device startup, you should establish the initial phase of your QMS when you have the necessary funds and are actively engaged in the design and development of a medical device. This phase should include:
- Design Controls: Developing a well-defined design control procedure is paramount for your medical device QS. Design control provides a systematic framework for capturing crucial aspects of medical device product development, ensuring your product meets user needs and adheres to safety and efficacy standards.
- Risk Management: Design control and risk management should go hand in hand. Keep in mind that risk management is a key focus of medical device regulators. They expect companies to establish risk management as an integral part of the product life cycle process.
- Document Control and Records Management: Document control and record management are interwoven throughout FDA and ISO 13485 standards. If an action or process is not documented, it is as though it didn’t occur. Robust documentation and record-keeping are vital not only during product development but also throughout your company’s existence.
- Supplier Management: Many medical device startups heavily rely on suppliers for critical materials and processes. Your QMS should define how you qualify, evaluate, monitor, and manage your suppliers. Maintaining an Approved Supplier List (ASL) is crucial.
Implementing these four QMS processes and diligently adhering to them during development is more than sufficient for your medical device quality system. In the subsequent phases of your QMS development, you will gradually integrate the remaining components to ensure continued compliance and product quality.
Some final advice on getting started
I will always recommend starting with a conversation with an experienced professional, if that’s an option. Seek out advice on where to start, how to plan, and what implementation might look like. Yes, there are many excellent eQMS tools rapidly gaining in popularity, but of course, the effectiveness of an eQMS tool depends on how well it aligns with your organisation’s plans, processes, culture, and of course, budget.
About the author
Amit Kakkar, Quality Manager has three decades of experience in Quality Management Systems across Medical Device Manufacturing, Electronics Manufacturing, and Product Design and Development sectors. He is a certified lead auditor with a expertise in ISO standards, including ISO 13485, ISO 9001, ISO 14001, ISO 14971, 21 CFR Part 820, together with TGA Medical Device Regulations. His broad career experience includes leading validation/re-validation processes and managing audits for the ongoing Conformity Assessment Certification of Class IIb medical devices.
