Photo from breakfast seminar with Ledidi in August 2026 at Oslo Science Park.
Ledidi and Mantra Systems were both started by clinicians who got frustrated with the same gap from opposite ends.
Paul Hercock trained as a surgeon and spent most of his clinical career in A&E. In 2014 he founded Mantra Medical to build bedside devices that let a nurse clean a blood pressure cuff or pulse oximeter in seconds between patients. The devices worked and the business was funded; what stopped it was the regulatory route. Paul went into industry to understand why, spending four years as a medical advisor on device regulation and safety, and in 2019 founded Mantra Systems to fix the problem from the other side: a Sheffield-based consultancy where clinicians and regulatory specialists work in the same team. Today they support UK and EU MDR and IVDR market access, clinical evaluation, SaMD approval and PMCF for over 500 clients, with a 100% submission success rate.
Einar Martin Aandahl was a surgeon. The data he needed to answer clinical questions existed, but it sat in silos, in legacy hospital systems and in spreadsheets that didn’t talk to each other, and getting it into a usable form took longer than the research itself. Ledidi came out of that: a no-code platform where sponsors design their own studies and registries, see their data in real time, analyse it in place, and keep it when the study ends. Validated for GCP and FDA 21 CFR Part 11, ISO 27001 and SOC 2 Type II certified.
What the two look like together
A division of labour. Mantra Systems handles the regulatory side: clinical evaluation strategy, the PMCF plan and protocol, questionnaire design, and the PMCF Evaluation Report that goes into the technical file. Ledidi handles the data side: enrolment, automated follow-up windows, monitoring, audit trail, analysis and export.
In practice, a manufacturer can run a PMCF programme where the regulatory expert designs the survey, patients and clinicians complete it in Ledidi, follow-ups go out on schedule without anyone chasing, and the evaluation report is written from a live, structured dataset instead of a manual Excel export.
PMCF is where we start, but it isn’t the whole of Mantra’s work. They also take SaMD and AI products through MDR and IVDR certification, write clinical evaluations across all risk classes, and help US manufacturers use existing FDA clearance to enter the UK and EU. Wherever a client’s regulatory strategy calls for new clinical data, whether that’s a clinical investigation before market or performance monitoring after it, Ledidi is the platform they can point to.
Each of us is honest about scope. Mantra doesn’t run clinical trials; Ledidi doesn’t write CERs. If a Mantra client needs a full clinical investigation, they’ll introduce Ledidi and CRO partners like Franklyn Health. If a Ledidi customer needs their PMCF strategy written by people who have done it hundreds of times, we’ll point them to Mantra. The referral runs both ways.
A word from Mantra Systems
"Designing a PMCF study is one thing. Making it successful in practice is another. What’s often missing is execution — whether it’s datapoint optimisation or a data collection system that works seamlessly. Ledidi is the ideal partner in this regard — their platform excels in the critical data side, leaving sponsors free to focus elsewhere. I’ve seen many platforms but Ledidi is well ahead of the pack for usability and adaptability, meaning we are very proud to be a partner organisation."
Who this is for
Device and diagnostics manufacturers with PMCF, PMS or clinical evaluation obligations under MDR or IVDR who are currently meeting them with a consultant’s plan on one side and a survey tool and spreadsheet on the other. PMCF isn’t a compliance tick box. Done properly it is real-world evidence about how your device performs, and most teams don’t realise the value sitting in the gap between the plan and the data.
You can find Mantra Systems at mantrasystems.com. To talk to us about a joint PMCF programme, get in touch or book a demo.