Engineering consultancy · Medical devices
Mindsence supports medical device manufacturers and medtech start-ups across the full product lifecycle: design engineering, European regulatory compliance, industrial strategy and the integration of artificial intelligence.
Services
One consistent goal: turning a technical or regulatory constraint into a clear, documented decision that holds up in front of a notified body.
Designing, developing and industrialising a medical device, from concept through to production transfer.
Building and defending a technical file that complies with the European medical device regulation.
Informing the product, industrial and regulatory decisions that commit the company for years to come.
Moving artificial intelligence from experiment to industrial use, with no regulatory blind spots.
Approach
Every assignment starts with a short, free scoping call. You know from the outset what will be delivered, when, and at what cost.
A one-hour conversation to qualify the need and identify technical and regulatory risks, followed by a written proposal covering scope, deliverables and schedule.
Working embedded in your teams or independently, with regular progress reviews. Deliverables are designed to slot straight into your document management system.
Nothing stays in my head: documentation, team training and method transfer, so that you are fully autonomous once the assignment ends.
About
A biomedical engineer trained at the University of Bologna, I have spent seven years in biomedical engineering, from research through to the medical device industry. I started in signal processing — at Oregon Health & Science University on Parkinson's disease, then at the University of Bologna, resulting in two scientific publications.
On the industry side, at Angiodroid I rolled out a CO₂ injector with more than fifty practitioners, across twenty-five hospitals in five countries — qualifying the need, designing the content, implementation and follow-up. Then, as an R&D engineer at Cefla France, I worked on medical imaging: weighing a product's features against technical constraints, clinical needs and deadlines, working directly with the clinical, project and sales teams.
I founded Mindsence in 2025 to put that experience at the service of medical device manufacturers. That dual background — research and field, product and user — is what lets me hold both ends of a project: the technical decision, and the file that will have to justify it.
Clients
Leading a technical and documentation integration programme following an acquisition: scoping, planning, coordination of internal teams and external providers, with direct reporting to management.
A study on the use of artificial intelligence for scientific literature surveillance in pharmacovigilance: research, assessment of existing solutions and their limitations, delivered as a presentation. Production, with the support of AI, of Environmental Risk Assessment (ERA) documentation compliant with EMA guidelines.
All assignments are carried out under the confidentiality agreements signed with each client. Trade marks mentioned remain the property of their respective owners, and their mention implies no affiliation or endorsement. Further references are available on request.
Contact
Describe your need in a few lines: I reply within one business day and we arrange a first call, with no commitment.
