Do you think of quality management as only one part of the progress of bringing your software device to the market? Preferably one that can be checked out as a last step before your software device enters the market? Our QA/RA specialist Linda Kellberg discusses the dramatic change, and the challenges software manufacturers are facing with the new medical device regulations. She predicts that especially new software manufacturing companies with no existing quality management system or experience in the medical field will struggle with dedicating resources to quality and regulatory affairs early on. This will create problems later down the line when the product is supposed to enter the market.  

MDR changes and the impact to SaMD 

Linda details how new classification of software devices is one of the biggest challenges software manufacturers are facing.

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“Things have changed. Before it was possible to classify most software devices to Class I”, Linda explains. “In practice, this meant that the device could be placed on the market without a Notified Body inspection, for example. Manufacturers could simply self-declare their devices and release them for use.” 

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However, under the new MDR regulation most software devices will end up in at least Class IIa instead, and therefore require a Notified Body inspection and CE certification before entering the market. Even so, many companies end up focusing solely on software development to get a functional prototype out as fast as possible to promote their solution. Quality management system is easily ignored to be established as the least step at the very end of the product realization process. 

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The truth is that it is no longer sufficient to start thinking about quality management at such a late stage. Under the new regulation, and especially due to the Notified Body inspection, overlooking the new quality regulations as long as possible will create problems and significantly slow down the process of bringing the new product into the market; significantly more than if the system requirements were considered right from the beginning.  

Avoiding the pitfalls 

“Companies might think they can purchase a ready-made QMS and be done with it. However, this way they will just end up with a QMS that does not actually fit into their operations, that no one wants to use because the procedures are so far from what they are actually doing, and which will become a burden that everyone just tries to avoid until it is no longer possible. One-size-fits-all is not an approach that can be – or should be - applied to a QMS”, Linda affirms. “When a fitting QMS is established early on, it will work alongside the development and support the team to achieve the necessary targets – whether company internal or regulatory.” 

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New companies with no existing QMS or other income streams aside from the upcoming product should pay special attention to the overall quality and regulatory umbrella: the scheduling and budget, the requirements and appropriate human resources; and establish a clear regulatory strategy from the start. 

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Three pitfalls. 

1. Trying to purchase an existing QMS in hopes of saving time and money
2. Not considering QMS from the very beginning, thinking it can be the final step
3. Not dedicating a human resource towards the QMS who can focus on it and make it work alongside other operations 

An experienced partner will help 

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New companies with no experience or existing quality systems will benefit from partnering with a qualified company that can help them with the development of the new product. Innokas Medical is a full-service partner for technology companies and specializes in medical technology.  Our Digious software house has a unique expertise in developing regulated medical software. We provide support and consultation with concepting, design, development, digital solutions, and quality and regulatory affairs amongst other services. If you have anything on your mind, we would be happy to hear it! 

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