There is a huge amount of information for medical device startups to learn and implement, not least of which is your regulatory obligations. This can be overwhelming – we get it!
If you’ve ever found yourself in a situation where you need to backtrack and piece together critical records or other key regulatory paperwork, you’ll understand the underlying reason why getting on top of things early makes sense. It’s hard to work backward!
The Quality Management System (QMS) is one of those things that startups frequently question. Most know they need one, they just don’t know exactly when. Other tasks seem like they might be more urgent – such as clinical trials or producing your first working prototype.
We’re here to pose to you that your QMS should be one of those regulatory obligations that you get onto sooner rather than later. It’s not just about meeting a requirement, it’s about having some best practices in place…
The role of the medical device QMS
What is the purpose of a medical device QMS? It is a system that establishes your company processes so that you will be compliant with regulations. The overall objective is to produce a safe, effective medical device.
Your QMS provides your team members with a guide as to how things should be done and helps you to maintain consistency across your policies and processes. It also acts as a record keeper so you can look back on what has been done and prove to regulatory authorities that requirements have been met.
A QMS isn’t just about regulatory compliance though, it’s about establishing an overall commitment to quality within your company. Your QMS provides you with the mechanism to continually improve, whether that’s the device itself or the processes you follow. It helps you to establish consistency across the company.
What happens if you don’t establish a QMS early?
Sometimes, companies are fortunate and face no great consequence for not establishing a QMS early, but that’s not the case for most. At the very least, they can run into delays getting to market as they work to put together the necessary documentation, at worst, they might experience an audit with multiple findings they need to take action on.
It’s easy to think in the early stages that documentation will be superfluous – “I’ll remember this,” you might think. However as time goes on and you work through changes, and the various stages of development, it becomes more and more difficult to remember those earlier stages.
In more extreme examples, some medical device companies have found themselves scrambling to construct a QMS and reconstruct design history, or various other documents that should have been established as they went through development. You can imagine the pressure when this is done in haste for a looming audit…
An important requirement of QMS across most established markets (including the US, Canada, and Europe) is that you must have design controls in place as described in ISO 13485 and 21 CFR 820. Manufacturing processes form part of those design controls and regulatory authorities may decide to inspect your manufacturing facility, including a check that those controls are in place. In the case of ISO audits, registrars may not want to grant a certificate with manufacturing scope if those processes aren’t yet established in your QMS.
The bottom line? You can experience expensive delays getting your device to market if you don’t have a QMS in place early. For some companies, those delays spell the end of the road, especially if they need to generate revenue sooner.
Reasons to establish your QMS early
If you’re still thinking that perhaps you’ll leave your QMS until later, here are a few good reasons to get onto it ASAP:
Device safety and efficacy
Having clear, established procedures helps to ensure you build a safe, effective device. After all, that’s the main goal of creating a new medical device! When procedures are inconsistent, the people who are meant to follow them will be too. This can easily lead to mishaps or important steps being overlooked.
Two of the absolute musts of a medical device QMS are Design Controls and Risk Management. We would easily argue that these are the most important aspects of your QMS to establish immediately as they determine the safety and efficacy of your device. From a regulatory perspective, establishing those procedures early helps to provide objective evidence that you have done what needs to be done to create a safe device.
Provide a framework for your team
Established quality procedures mean that no one should be reinventing the wheel each time the same issue comes up. It should be a matter of going to the documented procedure and following the guidelines.
Your QMS helps to provide guidance to team members and promote consistency. It’s a framework for “how we do things around here” and should reflect your expectations. This has the added benefit of creating efficiencies – when people can find the answer themselves in the documentation rather than having to ask questions, it saves time.
Stay on the right side of regulatory
While meeting regulations isn’t the only job of a QMS, it’s an important one. Having an established QMS is an absolute requirement for getting your device onto the market, period.
FDA expects you to have a QMS in place and to be following the regulations that go with it. If you leave this until late in your development, you’re going to have a painstaking job backtracking to establish your compliance.
You can also consider here the time-cost of having to reconstruct documentation for your QMS. For most companies, it’s much more efficient to do it as you go.
Help establish your vendor management policies
Many medical device startups rely on third-party vendors for various parts of the process, from design to testing to manufacturing. How you select and establish ongoing management of those vendors is crucial. They play a huge role in the overall quality of your product.
Your QMS should establish your vendor management procedures, covering everything from how to select them, the certifications they require, and the ongoing checks you will do. For example, what will you do if a manufacturer produces nonconforming parts? How will you determine that a third-party cloud platform has established strong data security protocols?
It’s important to have those procedures in place before selecting any vendors so that you have the best chance of choosing well.
Imagine the scenario where you wait until the stage where you’re ready to have your product approved for the market to establish your QMS. (This actually isn’t uncommon!). You suddenly discover that there are several things you should have done differently from the beginning of your development in order to get regulatory approval. You now have to go back and redo some key tasks to fill in the missing pieces.
There’s a good chance you’ll be double-handling some things and that overall, you end up spending more money this way. Had you developed a QMS in the beginning, you would have also had a better understanding of what was required for regulatory approval and should have gotten to that stage with everything already in place.
The bottom line for us is that a QMS should be established as early as possible in the development process for a new medical device. It acts as your guiding framework to ensure that you have strong processes, for everything from design controls and risk management, to manufacturing processes and vendor management.
It comes down to developing a safe, effective device that has a smooth pathway to market. Lack of strong processes can be inefficient and costly, but a well-established QMS helps to bring consistency.