When I founded Mantra Systems back in 2019, my mission was to make medical device regulatory approval a whole lot simpler than it sounds. I wanted to play a part in bringing more crucial medical device innovations to market through delivery of innovative services that streamlined approval pathways.
As we near the end of 2025, that focus remains exactly the same.
As a medical device regulatory consultancy, it would be easy for us to lose ourselves in a world of technical complexity. However, because we pride ourselves on listening to our customers’ needs, we are constantly reminded that our real business is problem solving. Our job is to identify and deliver the most efficient route to market for medical device innovators around the world. On a background of changing regulations, this certainly keeps us on our toes.
A changing regulatory landscape
As an example of this changing landscape, during the Autumn the MHRA announced an important change in their relationship with other regulatory frameworks around the world. By introducing International Reliance, the MHRA is enabling accelerated approvals in the UK for medical devices with existing accreditation in the US, Canada and Australia, alongside ongoing recognition of CE-marking under MDR and IVDR.
This is an important development - we regularly work with clients who have ambitions to enter multiple global territories; our role is to apply our understanding of the interplay between different regulatory environments to craft the pathway with least resistance to achievement of commercial objectives. This work continues to be stimulating and thought-provoking, with no time to stand still.
A focus on customer need
At Mantra Systems, 2025 has been a year of further growth and expansion alongside, perhaps paradoxically, a re-focus on what we do best. While it’s always tempting to spread horizontally into new services where demand can be identified, we’ve instead recognized that we best serve our customers through a re-positioning of our existing services. This means more granular service packages aimed at, amongst others, manufacturers based in the US, Chinese manufacturers, Class I device manufacturers, and Software-as-a-Medical-Device (SaMD) developers. All need similar core components but require a different form of expression, emphasis and delivery.
Speaking of SaMD, a significant introduction this year is our Accelerated SaMD Approval Service, with the potential to save an entire year off the approval pathway for SaMD products. For funded and ambitious developers seeking to generate a fast return for investors while securing market position and first-mover advantage, it’s a service with enormous potential and significant early interest.
A further exciting addition is the launch of QMS Jumpstart, our e-QMS system geared specifically to early-stage companies. While many existing e-QMS offerings are focused on the needs of more established companies, we believe that offering solutions to early-stage companies is a great way to support innovation at its roots. While not all such companies will go on to commercial success – such is the reality of innovations – we believe passionately in offering solutions that are within scope, budget and experience of early-stage companies.
This also underpins our introduction of our Fractional Consulting service, wherein our team becomes your ‘virtual compliance department’ for a single fixed and all-inclusive monthly fee. It’s proven to be a great option for companies looking to build traction on their compliance journey while balancing a tighter budget and more predictable monthly spend.
And what of 2026?
As we approach the end of the year, it’s natural that our attentions turn to what 2026 might have in store. Just in the last few days, the European Commission has published a Proposal for modifications to the MDR and IVDR themselves. Highlighting challenges stemming from the implementation of MDR and IVDR, the proposal is the most solid suggestion yet that the MDR and IVDR in their current form might not be forever. This proposal aims to “simplify the applicable rules, reduce the administrative burden on manufacturers and enhance the predictability and cost-efficiency of the certification procedure by notified bodies, while preserving a high level of public health protection and patient safety.” Whether the proposal moves forward, of course, remains to be seen.
Next year will also likely see the formal introduction of the ISO 18969 standard for Clinical Evaluation of medical devices, currently published in draft form. Initial concerns amongst many that existing approaches to clinical evaluation would have to be ‘thrown out’ appear unfounded, with the standard complementing rather than replacing guidance from relevant MedDev and MDCG guidelines.
From a Mantra Systems perspective, 2026 will see a continuation of our drive to offer ever more value to the market. Recent webinars on SaMD, Cyber Security and the MDR for US-based Manufacturers are just the start, so be sure to follow us on LinkedIn or subscribe to our Newsletter to stay up to date. We’re also releasing a range of new tools, White Papers and other freebies to help make your MDR and IVDR experience quicker and smoother. Furthermore, our work to tailor services to the specific needs of customer groups will continue apace, meaning that before long there’s likely to be an offering geared specifically to your needs. Again – follow Mantra Systems to find out more.
Overall, it’s been an exciting and successful year and we enter 2026 full of optimism for continued growth and development of our innovative company. Our mission to simplify the complex and bring better healthcare innovations to market appears to resonate with many, and we intend to build on this solid momentum as we approach the next 12 months in our journey.
I’d like to express my sincere gratitude to all of our customers – the trust you place in us to serve your compliance needs is a true honor, and we take great pride in the quality of our working relationships across the board. Thank you to our partners, whose exceptional services complement our own while adding value to the customer experience across the board.
Finally, and perhaps most importantly, no measure of success is possible without an incredible team. At Mantra Systems, our team members are, quite simply, everything. I remain humbled every day to work alongside such exceptional individuals, and am filled with gratitude that you choose to work with us.
Here’s to an exciting and prosperous 2026 - I wish you all a very Merry Christmas and a very Happy New Year.
