Medical Device Product Development
We design the electronics, firmware and embedded software inside medical devices, and the evidence a regulator expects to see with them. The work runs inside your ISO 13485 quality system, from the first feasibility build to the handover to manufacturing. One system we built end to end has US FDA 510(k) clearance.
What We Deliver
What does a medical device development partner actually take on?
The engineering of the device, end to end or only the part you need: electronics, firmware, embedded software, enclosure prototypes and the test evidence behind each one. Your team keeps the clinical and regulatory lead, and design decisions are written down so they can be traced when the submission is put together.
From concept
- Clinical and user needs turned into written design inputs
- Feasibility builds that test the riskiest idea first
- System architecture for standalone and connected devices
- Electronics, PCB design and layout
- Firmware and embedded software, including the user interface
- 3D printed and CNC-machined enclosure prototypes
To launch
- Verification against every design input, with the evidence filed
- Pre-compliance testing before the formal laboratory visit
- Risk management to ISO 14971, kept current through the programme
- Usability engineering to IEC 62366-1
- Design and test documentation for your submission
- Transfer to manufacturing, and support for updates after launch
Concept to Clinic
How does a medical device move from concept to clinic with us?
In stages, each closing with a review you sign before the next one starts. What changes from one programme to the next is where the risk sits, and how early we go after it.
Concept and feasibility
We turn the clinical need into requirements you can test, and build the least certain part first.
- Design inputs agreed in writing
- A feasibility build on the riskiest function
- Risk analysis started on day one
Design and prototypes
Electronics, firmware and enclosure are developed together, so the first integrated prototype is not the first time they meet.
- Schematic and layout reviewed before fabrication
- Firmware proved on evaluation hardware while boards are made
- Enclosure prototypes, 3D printed or CNC-machined
Verification and transfer
Testing against every requirement, pre-compliance before the laboratory, then a handover to manufacturing.
- Verification evidence filed against each requirement
- EMC pre-compliance scans to IEC 60601-1-2
- Transfer to production with a written test procedure
Case Studies
Which medical devices have you built?
Three are written up in full. Client names stay confidential; the engineering and the outcomes are on the record.
Case study
Four devices built end to end for a European medical device company, from concept to a system ready for 510(k) submission in under 18 months.
Case study
A 1000 W convective warming system that passed IEC 60601 safety and EMC testing in the first round, approved under EU MDR (CE marking) and by CDSCO.
Case study
The BLDC motor controller and firmware for a US medical device company. Prototypes accepted by the client.
Standards and Approvals
Which standards and approvals do you design for?
The standards your device will be tested against, and the approvals it will be submitted for, are fixed at the start and drive every design review. We are deliberately not ISO 13485 certified ourselves: we work inside your quality system, so the records belong to it from the start. If you do not have one yet, we help you set it up.
Standards
- IEC 60601-1, basic safety and essential performance
- IEC 60601-1-2, electromagnetic disturbances (EMC)
- ISO 14971, risk management
- IEC 62366-1, usability engineering
Clearances and approvals our work has supported
- US FDA 510(k)
- EU MDR (CE marking)
- CDSCO, India
The software lifecycle under IEC 62304, and software that is itself the medical device, are covered on our medical device software development page.
Quality
How do you stop a medical device failing at the test laboratory?
By testing before the laboratory does. Most failures at a certification test come from design decisions made months earlier, so the checks move to where those decisions are made.
Isolation from the first schematic
Creepage, clearance and leakage current are designed into the first schematic and checked against IEC 60601-1 before the layout is final.
EMC as a design input
Filtering, layout and grounding are chosen for emissions and immunity at the start, then checked with pre-compliance scans before the formal test.
Findings with an owner
Review findings are logged, assigned to a person and closed before release, and you can see the list at any time.
Laboratory time in the plan
Certification testing at an accredited laboratory is planned into the schedule from the start, not booked at the end.
Why Pinetics
How do you know a medical device partner will deliver?
100,000+ engineering hours delivered and counting.
On a medical programme, you see the time booked against each task, and the evidence is built as the work happens rather than reconstructed before a submission.
Expertise
Medical work in patient warming, cardiovascular diagnostics and a surgical drill, led by founders who are engineers and sit in the design reviews.
Technology
A sensor watch, a 1000 W warming system and a battery-powered surgical drill, each with firmware written for its own hardware.
Transparency
Your quality system holds the records, your team signs every gate, and you own every design file and line of code we produce.
Common Questions
What should you ask before choosing a medical device development partner?
Pinetics designs electronics, firmware and embedded software for medical devices, from the first feasibility build to the transfer to manufacturing, with the test evidence for each. Our case studies include a US FDA 510(k)-cleared cardiovascular diagnostic system and a patient warming system approved under EU MDR and by CDSCO.
Yes. We design medical electronics for IEC 60601 safety and electromagnetic compatibility, with risk management to ISO 14971 running from the first design review. One system we built received US FDA 510(k) clearance. Another passed IEC 60601 safety and EMC testing in the first round and was approved under EU MDR and by CDSCO.
Yes. A programme can start with a clinical idea and a sketch. If you do not have an ISO 13485 quality system yet, we help you set one up. We help define what the first prototype has to prove, build it, and set up the requirement and risk records so the work counts towards the eventual submission instead of being redone.
Yes, and most first conversations start that way. Send yours or ask for ours.
Yes. We prepare the design for production and write the production test procedure. Then we hand the design to a manufacturer certified to ISO 13485 for medical devices, and support updates after launch.
We engineer for the submission and produce the design and test documentation it needs. The filing is made by your regulatory team or consultant, or by a consultant we bring in. On the 510(k)-cleared system in our case studies, we delivered the design and test documentation for the submission.
Yes: working boards, firmware and 3D printed or CNC-machined enclosures, verified against the design inputs. Clinical validation stays with you and your clinical partners, and we supply the units and the data that work needs.
A multi-role core delivery team, with specialists engaged per phase. Our founders, who are engineers, take part in the design reviews.