Medical Device Manufacturing Test Equipment Calibration — FDA QSR / ISO 13485

Medical Device Manufacturing

ISO/IEC 17025:2017 accredited calibration, repair, and sales / rentals of biomedical analyzers, IEC 60601 electrical-safety testers, dimensional metrology, and cleanroom test equipment for FDA QSR and ISO 13485 production lines · ANAB Certificate AC-1736

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Medical Device Manufacturing Services

Techmaster Electronics serves FDA-registered medical device OEMs, ISO 13485-certified contract manufacturers, implant and catheter producers, and surgical-robotics labs. From IEC 60601 production-line electrical-safety analyzers and implant-screw push-out test stations to ISO 13485 cleanroom particle counters and sterile-barrier packaging validation, our 5 US labs deliver FDA QSR-aligned services.

Calibration for Medical Device Mfg

Top calibration disciplines for medical device manufacturing under FDA QSR / ISO 13485.

🩺Medical / BiomedicalDefibrillator analyzers, ESU / infusion pump testers, vent / SpO2 simulators, patient-monitor sims.See medical cal →📏DimensionalImplant geometry, catheter OD, stent strut width with sub-micron CMM traceability.See dimensional cal →⚡ElectricalIEC 60601-1 safety analyzers, leakage current meters, hipot testers, isolation transformers.See electrical cal →🧪Cleanroom CertificationISO 13485 cleanroom particle counting and ISO 11607 sterile-barrier packaging chambers.See cleanroom cert →

Repair for Medical Device Mfg

Factory-trained repair for the analyzers behind FDA QSR / ISO 13485 production-line test.

🔧Medical RepairFluke Impulse 7000, IDA-5, QA-ES III, ESA612 analyzer repair with traceable post-repair cal.See medical repair →⚙️Electrical RepairIEC 60601 safety analyzer and isolation transformer repair for production-line test stations.See electrical repair →🛠️Environmental RepairISO 11607 packaging chamber and accelerated-aging oven controller refurbishment.See env repair →

Sales & Rentals for Medical Device Mfg

Authorized partner sales and project rentals for medical device manufacturers.

🛒Medical EquipmentFluke ProSim, Impulse 7000, IDA-5, ESA612 for production-line final-test stations.Shop medical gear →📦Dimensional SalesZeiss / Hexagon / Mitutoyo CMMs for implant inspection, stent strut, catheter OD.Shop CMMs →🚚Environmental ChambersISO 11607 packaging-stability chambers and accelerated-aging ovens.Shop chambers →

Compliance & Industry Standards

Techmaster cal certificates satisfy the audit requirements of every major medical-device quality framework:

21 CFR Part 820 (FDA QSR) · 21 CFR Part 11 electronic records · ISO 13485:2016 medical device QMS · ISO 14971 risk management · IEC 60601-1 medical electrical safety · IEC 60601-1-2 medical EMC · ISO 10993 biocompatibility · ISO 11607 sterile-barrier packaging · ISO 11135 / 11137 ETO and radiation sterilization · ISO 11607 packaging · EU MDR 2017/745 · EU IVDR 2017/746 · FDA UDI unique device identifier

UUTs We Calibrate

Comprehensive list of Unit-Under-Test (UUT) instruments customers in this industry typically send to Techmaster for ISO/IEC 17025 accredited calibration. Click any linked item for a deep-dive article on its calibration procedure, uncertainty budget, and typical failure modes.

Patient-Simulation & Defib Test UUT

  • Defibrillator Analyzer
  • AED Analyzer
  • Patient Monitor Simulator
  • ECG Simulator
  • SpO2 Simulator
  • NIBP Simulator
  • Vital Signs Simulator
  • Pulse Oximeter Tester

ESU / Infusion / Ventilator UUT

Electrical Safety (IEC 60601) UUT

Dimensional (Implant / Catheter) UUT

Mass & Force (Implant Push-Out) UUT

Environmental & Sterilization UUT

Need IEC 60601 safety-analyzer cal, sub-micron implant inspection, or ISO 13485 cleanroom?

Our medical-device specialists handle IEC 60601-1 / -1-2 production-line analyzer calibration, sub-micron CMM verification for implants and catheters, ISO 13485 cleanroom certification, and ISO 11607 packaging-stability chamber qualification.

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Frequently Asked Questions

Common questions about Techmaster medical device manufacturing test equipment services.

Are your cal certs accepted on FDA / ISO 13485 audits?
Yes. Our ANAB-accredited ISO/IEC 17025 cal certs are accepted on FDA 21 CFR 820 (QSR), ISO 13485 surveillance audits, EU MDR Notified Body inspections, and Health Canada audits at Medtronic, Boston Scientific, J&J, Stryker, Abbott, Edwards, and BD supplier networks.
Do you calibrate IEC 60601 electrical safety analyzers?
Yes. Fluke ESA612 / ESA620, BC Group ESA620, and Datrend vPad-ES analyzers are calibrated with NIST-traceable resistance, leakage current, and ground-bond standards per IEC 60601-1 third-edition test methodology.
Can you support sub-micron CMM inspection for implants?
Yes. Our dimensional metrologists verify Zeiss CONTURA, Hexagon Optiv, and Mitutoyo CRYSTA-Apex CMMs to ISO 10360-2 with grade-AA artifacts — ideal for orthopedic-screw, spinal-cage, stent-strut, and catheter-OD inspection.
Can you perform on-site cleanroom certification for medical-device manufacturing?
Yes. ISO 14644 cleanroom certification is performed on-site at medical-device production facilities — sterile-implant assembly, IV catheter mfg, dialysis cartridge mfg, and sterile-barrier packaging lines.
Which Techmaster locations serve medical-device customers?
All five US labs serve medical-device manufacturers: Vista CA (Southern California medtech), Santa Clara CA (Genentech-area biotech), Orlando FL (Florida medtech), San Antonio TX (Texas Medical Center), and Holly Springs NC (RTP medtech cluster).

Ready for a medical-device calibration proposal?

Send us your production-line instrument list, target FDA / ISO 13485 / IEC standards, and audit cadence. We will respond within one business day with a scope proposal.

Get a Quotesales@techmaster.us