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Class I and II diagnostic devices, patient monitors, and surgical instruments. IEC 62304 software, ISO 13485-aligned design controls, and ISO 14971 risk management from requirements to verification. When Ford needed a ventilator built fast, this is the discipline that got it cleared.
Hardware, software, and documentation for programs that have to clear regulatory review the first time.
Patient monitors, signal chains, and connected hardware designed with IEC 60601 electrical-safety awareness.
Class A, B, and C software with requirements traceability, architecture, unit testing, and software hazard analysis.
Design-for-manufacture and Design History File aligned to an ISO 13485-based quality system, ready for your QMS.
ISO 14971 risk management across the life cycle, plus verification protocols and validation studies written before build.
Four phases, each closing with regulatory-grade documentation you sign off before the next begins.
User needs, design inputs, and ISO 14971 risk analysis. Regulatory pathway (510(k), De Novo, PMA) defined up front.
Hardware, IEC 62304 software, and mechanical design with a full traceability matrix. Verification protocols written before build.
Verification testing, validation studies, and Design History File close-out ready for submission.
Manufacturing on an ISO 13485-aligned line, with Device Master Record and process validation per device.
The standards a medical program has to answer to, mapped to the work we deliver against each one.
Design controls and Design History File aligned to an ISO 13485-based QMS, ready to hand to your quality team
Class A, B, and C software: requirements traceability, architecture, unit testing, and software hazard analysis
Hazard analysis, risk controls, and residual-risk evaluation maintained across the full product life cycle
Medical-electrical design awareness and pre-compliance checks for patient-facing hardware
USP Class VI materials and sterilization-aware design for autoclave, EtO, gamma, or chemical methods
510(k), De Novo, and PMA support: verification reports and risk file delivered in submission format
Share your requirements and our engineers walk the design before tooling. Risk, materials, and traceability flagged so your quality process, from design controls to V&V, starts clean.
Requirements, risk analysis, and a design history trail your quality team can build on.
Materials and finishes matched to skin contact, cleaning, and sterilization.
Documentation and test points structured to support your V&V and submissions.
Biocompatible polymers and finishes chosen for skin contact, cleaning, and the sterilization method your device needs. Here is how the common options compare.
Ratings are a general guide. Final material selection is confirmed with your requirements, contact type, and sterilization method during the design-controls review.
Standards, scope, and what to expect on a Jaycon medical engagement.
Our design and manufacturing processes are aligned to ISO 13485:2016. For programs that need a certificate under our QMS, we engage our ISO 13485-certified manufacturing partners.
We deliver the Design History File, verification reports, and risk file in 510(k) or De Novo format. We work alongside your regulatory consultant, or partner with one of ours for the actual submission.
Yes. Class A, B, and C lifecycle. Requirements traceability, software architecture, unit testing, and software hazard analysis are all delivered as part of the DHF.
Autoclave (steam), EtO, gamma, and chemical (Cidex). Material selection and tolerance budget are tuned to the chosen method up front.
From product design and rapid prototyping to precision injection molding and circuit board manufacturing.
We take your idea from sketch to working prototype, with a team that handles both the look and the engineering.
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Custom PCB design and assembly, reviewed by engineers before production so nothing gets built twice.
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Get a physical part in your hands fast. We use the right technology for your design so you can test and move forward.
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When you are ready to scale, we handle the tooling and run production so you can focus on your business.
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