DTECHENGINEERING

The engineering and compliance partner for medical device startups.

From a solo founder with a simple idea to a small team preparing for market, D-Tech designs the electronics and firmware with IEC 60601 in mind, runs EMC pre-compliance testing, and sets up the quality and regulatory work you need to launch.

Discuss your project
Standards we work withIEC 60601-1IEC 60601-1-2CISPR 11IEC 62304ISO 14971ISO 13485

Your engineering partner, start to finish

Four areas of support. Use one, or all of them as your product grows.

01Design and buildElectronics, firmware, and user interfaces, plus help when a part goes end-of-life.Learn more →02Test and complianceSafety testing, EMC pre-compliance, reliability testing, and design support for IEC 60601.Learn more →03Quality and regulatoryISO 13485 documentation and EU MDR, FDA, and MDSAP preparation sized for small teams.Learn more →04Production supportTest fixtures, field failure analysis, cost reduction, and training.Learn more →

Built for early-stage teams

Startups need to move fast without carrying a full engineering and quality department. D-Tech fills those roles for as long as you need them.

One partner, not five vendorsElectronics, firmware, safety testing, quality system, and regulatory support from a single team that already works together.
Engage as much as you needBring us in for one task, a defined project, or ongoing support, and scale up or down as funding and milestones change.
Find problems while they're cheapBench safety checks and EMC pre-compliance before you spend on a full test lab campaign.
Quality support without the big-firm overheadExperienced ISO 13485 help delivered as consulting, sized for a small team and able to grow with the company.

From idea to launch

The same seven phases shown above. D-Tech can take on one, several, or all of them.

01IdeaTurn the concept into clear requirements and risks.
02ProofBuild a quick prototype to prove it is feasible.
03DesignElectronics, firmware, and interface, designed with the standards in mind.
04ReliabilityStress, life, and environmental testing, with failure analysis.
05VerifySafety testing and EMC pre-compliance against the standards.
06SubmitQuality system and regulatory documentation.
07LaunchProduction transfer, test fixtures, and parts changes.

The first step toward a smoother launch

Describe your device and where you are. D-Tech will suggest a sensible next step.

Tell us about your device