DTECHENGINEERING

Solutions

Engineering, testing, and compliance support, mapped to the phase of your product.

Three ways D-Tech helps

Hire D-Tech for a single task or carry a product from schematic through to market clearance.

Design and build

  • Electrical engineeringCircuit design, review, and debugging for battery and mains powered products.
    Schematic and PCB layout (Altium, OrCAD) · High-voltage and isolated drive circuits · Sensor and optical front ends · Worst-case analysis
    Phases: Proof · Design
  • Embedded programmingFirmware for microcontrollers and real-time systems, written to medical software practices.
    C, C++, C# · dsPIC and PIC microcontrollers · PLD logic (Xilinx, Altera) · Production and test firmware
    Phases: Proof · Design
  • GUI developmentTouchscreen and embedded interfaces that are clear to clinicians and easy to verify.
    Phases: Design
  • Medical device developmentHands-on support through prototype, verification, and production transfer.
    Concept to launch · NPD and NPI support · Verification and validation · Cost reduction
    Phases: Proof · Design · Launch
  • Component obsolescence supportFinding and qualifying replacements for end-of-life parts, or redesigning the affected circuit when no drop-in alternative exists.
    Alternate part search · Compatibility testing on existing PCBs · Redesign and retest · Change documentation
    Phases: Design · Launch

Test and compliance

  • IEC 60601 serviceStandard interpretation, test strategy, and documentation for your test lab.
    Test planning · Safety test equipment · Documentation for your lab
    Phases: Design · Verify
  • Electrical safety testingLeakage current, dielectric strength, and protective earth checks.
    Hi-pot · Leakage current · Ground bond · Test equipment design and upkeep
    Phases: Verify
  • EMC pre-complianceEarly emissions and immunity checks that find problems before a full lab campaign.
    Phases: Design · Verify
  • Reliability testingStress and life-test planning, bench testing, and failure analysis to find weak points before customers do.
    Test planning · Failure analysis · Design improvements
    Phases: Reliability

Quality and regulatory

  • Quality management systemsHands-on ISO 13485 and ISO 9001 documentation, implementation, and remediation support, sized for small teams.
    ISO 13485 and ISO 9001 · QMS documentation · MDSAP readiness · Supplier controls
    D-Tech is a consulting practice and does not issue ISO certificates. Certification comes from an accredited registrar.
    Phases: Submit · Launch
  • Regulatory servicesPreparation for EU MDR and MDSAP, from gap assessment to technical documentation.
    EU MDR technical documentation · FDA compliance · MDSAP
    Phases: Submit

Where do you find yourself?

Most clients arrive at one of these points. Join at any phase.

Idea · ProofWe have an idea, but no design yetD-Tech turns it into requirements and a quick feasibility prototype.
DesignThe prototype works on the bench, but isn't ready for usersProduction-ready electronics, firmware, and interface.
ReliabilityWe're worried about weak points and field failuresStress and life-test planning, bench testing, and failure analysis.
VerifyWe're nervous about safety and EMC testingPre-compliance checks while changes are still cheap.
SubmitWe need a quality system and documents to submitISO 13485 documentation and regulatory preparation sized for a small team.
Design · LaunchA key part is going end-of-lifeFinding and qualifying replacements, or redesigning the circuit.

Not sure where to start?

Describe your device and its stage, and D-Tech will suggest the next step.

Tell us about your device

From the bench to the production floor

Getting a device designed is half the job. D-Tech also helps you build, test, and keep it consistent in manufacturing.

MCUPMICJ1D-TECH · REV A
Test fixtures and stationsDesign and documentation of production test fixtures and stations, including IQ/OQ protocols.
Verification and validationSystem test protocols and test programs that support design verification and validation.
Field failure analysisRoot-cause work on returned assemblies, with corrective changes fed back into the design.
Design for manufacturingMechanical parts, assemblies, and fixtures modeled in SolidWorks and AutoCAD.
Cost reductionReviewing designs and suppliers to cut cost without hurting quality or compliance.
Training and handoffTraining for your manufacturing and vendor staff on new or updated products and procedures.

What an early scan shows

Two illustrative pre-compliance scans: radiated emissions on the left, conducted emissions on the right. Catching a peak like these on the bench is far cheaper than at the lab.

CISPR 11 RADIATED EMISSIONS · GROUP 1 CLASS B · 10 mVerticalHorizontalLimit (Class B)010203040506030601003001000dBµV/m152 MHz · 33.4 dBµV/m3.4 dB over limitIllustrative sample, not measured dataFrequency (MHz)CISPR 11 CONDUCTED EMISSIONS · GROUP 1 CLASS B · MAINS PORTQuasi-peakAverageQP limitAvg limit010203040506070800.150.5151030dBµV400 kHz · 49.6 dBµV (avg)1.8 dB over limitIllustrative sample, not measured dataFrequency (MHz)