“When do I need a Quality Management System (QMS)?” is the most common question that we get asked by new clients who are just entering into the medical device field. The answer depends on your target market and your exit strategy. To be frank, it is somewhat a chicken and egg thing.
This blog is intended to aid start-up medical device companies determine when to start thinking about setting up a QMS. Establishing a QMS can take up to 3-9 months. I strongly advise our clients to have business and regulatory strategy well aligned as early as possible.
You need to implement QMS before you can get a Health Canada Medical Device (HCMD) license. More specifically, you need to go through a Medical Single Audit Program (MDSAP) ISO 13485 audit and submit copy of your certificate with your application.
For a CE Mark, you need to show that you have a formal QMS – the easiest way to demonstrate compliance is by submitting an ISO 13485 certificate. So, you need to spend months setting up your QMS and going through audits before you can get the HCMD license and CE Mark that will allow you to market and sell a medical device in Canada and EU.
US requirements are different. Assuming that the company is developing a Class II medical device, the FDA does not require a QMS until the device is cleared via 510(K) process and ready to be marketed in the US. The Class III device process is more demanding; as a part of Premarket Approval (PMA), the FDA would conduct a premarket inspection of the manufacturing facility. For Class I, you should implement a QMS at the time you start to sell the device in US market.
There is no formal requirement for the design and development stage to be done under a QMS umbrella. But this is where the chicken and egg thing comes into play. If you don’t have a QMS, you cannot produce acceptable documentation for regulatory submission. A Design History File (DHF) or technical file has to demonstrate that you had in place document record control, design control, change control, risk management, human factors procedures, etc. – just to mention the key ones.
Many start-up companies work with an established medical device developer and manufacturer that has an established QMS to close this gap. The StarFish version is a service which we call ‘QMS-in-a-Box’. QMS-in-a-Box includes all applicable procedures, forms and templates. We help start-ups implement the procedures, assist with ISO audits, etc.
The decision when to develop an in-house QMS will depend upon your business strategy. Do you want to be the manufacturer of the device or simply sell the technology? Based on all of the above, if you are planning to sell the technology, the FDA is your best choice because you can get the 510(K) without the registrar’s audit and certification of your QMS. If you are targeting Canada or EU, you will need to set up a QMS before you can get the HCMD license or CE Mark. Also, if you are planning to market the device in the US, you will need to have a QMS in place before the first sale of the device.
Vesna Janic is a Director of Quality/Regulatory at StarFish Medical. She uses her expertise in quality systems and regulatory compliance to guide our QA/RA team and help clients avoid wasting time on their path to market.
Photo credit: Vladimir Valastiak