# Sigma Scientific

> Medical device safety and performance testing


## Posts

- [ASCA Program Future Outlook for Device Teams](https://sigmascientific.us/insights/asca-program-future-outlook/): ASCA program future outlook for medical device teams: likely priorities, practical submission planning, and how accredited testing supports FDA readiness.
- [Guide to Transducer Sensitivity Testing for Medical Devices](https://sigmascientific.us/insights/guide-to-transducer-sensitivity-testing-medical-devices/): A guide to transducer sensitivity testing for medical device teams, covering setup, calibration, uncertainty, acceptance criteria, and compliant records.
- [How Accredited Laboratories Support Device Submissions](https://sigmascientific.us/insights/accredited-laboratories-device-submissions/): Accredited laboratories provide defensible medical device test data, defined scope, and documentation that support efficient regulatory review and release.
- [Clinical Evaluation for Medical Device Evidence](https://sigmascientific.us/insights/clinical-evaluation-medical-device-evidence/): Clinical evaluation provides a structured assessment of device safety, performance, and benefit to support regulatory submissions and market access work.
- [Medical Device Test Report Review for Submissions](https://sigmascientific.us/insights/medical-device-test-report-review/): A medical device test report review checks methods, data, deviations, and conclusions so results can support a defensible regulatory submission package.
- [ASCA Laboratory Guide for Device Manufacturers](https://sigmascientific.us/insights/asca-laboratory-guide-device-manufacturers/): ASCA laboratory guide for medical device teams: understand FDA-recognized testing, accreditation scope, report quality, and efficient submission planning.
- [Ultrasound Uncertainty Analysis for Compliance](https://sigmascientific.us/insights/ultrasound-uncertainty-analysis-compliance/): Ultrasound uncertainty analysis supports defensible acoustic output data, clearer risk decisions, and FDA submission documentation for medical devices.
- [A Practical Guide to Medical Device EMC Testing](https://sigmascientific.us/insights/guide-to-medical-device-emc-testing/): This guide to medical device EMC explains test planning, IEC 60601-1-2 requirements, risk controls, and documentation for regulatory submission review.
- [ISO 14971 Versus IEC 62366: Key Differences](https://sigmascientific.us/insights/iso-14971-versus-iec-62366/): Compare ISO 14971 versus IEC 62366 for medical devices: risk management, usability engineering, validation evidence, and practical compliance planning.
- [What Is Dielectric Withstand Testing in Devices?](https://sigmascientific.us/insights/what-is-dielectric-withstand-testing/): What is dielectric withstand testing? Learn how medical device labs verify insulation strength, protect patients, and support IEC safety compliance files.
- [Medical Device Materials Characterization](https://sigmascientific.us/insights/medical-device-materials-characterization/): Medical device materials characterization generates defensible data on composition, chemistry, surfaces, and aging to support device safety and submissions.
- [How to Conduct Catheter Tensile Testing Correctly](https://sigmascientific.us/insights/conduct-catheter-tensile-testing/): Learn how to conduct catheter tensile testing with defined fixtures, conditioning, force measurements, and documentation for regulatory-ready verification.
- [Test Report Review for Medical Device Evidence](https://sigmascientific.us/insights/test-report-review-medical-device-evidence/): A test report review verifies medical device evidence is complete, traceable, and aligned with applicable standards before regulatory submission or release.
- [How to Document IEC 62366 Validation Evidence](https://sigmascientific.us/insights/document-iec-62366-validation-evidence/): Learn how to document IEC 62366 validation with traceable use scenarios, formative evidence, summative results, and defensible usability engineering file.
- [Best Medical Device Test Protocols for Compliance](https://sigmascientific.us/insights/best-medical-device-test-protocols/): Learn how to select best medical device test protocols by risk, intended use, standards, and submission needs to generate defensible compliance evidence.
- [Patient Monitor Alarm Testing for Compliance](https://sigmascientific.us/insights/patient-monitor-alarm-testing/): Patient monitor alarm testing verifies audibility, priority, usability, and documented performance needed to support IEC 60601-1-8 compliance reviews.
- [EMC Precompliance Versus Formal Certification](https://sigmascientific.us/insights/emc-precompliance-versus-formal-certification/): EMC precompliance versus formal certification: learn when each test stage reduces medical device risk, rework, and regulatory submission delays early.
- [Ultrasound Compliance Evidence That Holds Up](https://sigmascientific.us/insights/ultrasound-compliance-evidence-that-holds-up/): Ultrasound compliance requires evidence that acoustic output, thermal and mechanical indices, imaging performance, and electrical safety meet standards.
- [FDA ASCA Eligibility: What Device Teams Need](https://sigmascientific.us/insights/fda-asca-eligibility/): FDA ASCA eligibility affects how medical device test reports support FDA submissions. Learn the scope, evidence, and laboratory considerations for teams.
- [Clinical Evaluation vs Bench Testing: When Each Applies](https://sigmascientific.us/insights/clinical-evaluation-vs-bench-testing/): Clinical evaluation vs bench testing: learn how each evidence stream supports medical device safety, performance claims, risk management, and submissions.
- [How to Perform a Medical Device Usability Study](https://sigmascientific.us/insights/perform-medical-device-usability-study/): Learn how to perform a device usability study that produces clear human factors evidence, supports risk controls, and strengthens regulatory submissions.
- [A Practical Guide to Catheter Fatigue Testing](https://sigmascientific.us/insights/guide-to-catheter-fatigue-testing/): This guide to catheter fatigue testing explains test design, loading, inspection, and documentation for durable, submission-ready device evidence sets.
- [How Long Does ASCA Take for Medical Device Labs?](https://sigmascientific.us/insights/how-long-does-asca-take/): How long does ASCA take? Review FDA accreditation stages, typical timing drivers, and submission planning for medical device testing laboratories today.
- [How to Reduce Ultrasound Thermal Index Safely](https://sigmascientific.us/insights/reduce-ultrasound-thermal-index/): Learn how to reduce ultrasound thermal index with output controls, mode design, verification, and standards-based evidence for FDA regulatory review.
- [Clinical Safety Effectiveness Testing Explained](https://sigmascientific.us/insights/clinical-safety-effectiveness-testing/): Clinical safety effectiveness testing generates the evidence needed to support medical device safety, performance, usability, and regulatory submissions.
- [Usability Engineering for Medical Device Validation](https://sigmascientific.us/insights/usability-engineering-medical-device-validation/): Usability engineering helps medical device teams identify use-related risks, validate critical tasks, and prepare evidence for FDA regulatory submissions.
- [Physiotherapy Equipment Performance Testing](https://sigmascientific.us/insights/physiotherapy-equipment-performance-testing/): Physiotherapy equipment performance testing verifies output accuracy, electrical safety, and controls, generating evidence for compliant market access.
- [Formative Versus Summative Usability Testing](https://sigmascientific.us/insights/formative-versus-summative-usability-testing/): Formative versus summative usability testing helps medical device teams generate the right human factors evidence at the right development stage reliably.
- [Endoscope Leakage Current Testing for Compliance](https://sigmascientific.us/insights/endoscope-leakage-current-testing/): Endoscope leakage current testing verifies electrical safety under IEC 60601-1 and relevant conditions, supporting compliance evidence for submissions.
- [How to Assess Usability Validation Evidence](https://sigmascientific.us/insights/how-to-assess-usability-validation/): Learn how to assess usability validation evidence for medical devices, from intended users and critical tasks to protocol rigor, findings, and records.
- [What an ASCA Accreditation Review Should Confirm](https://sigmascientific.us/insights/asca-accreditation-review/): Prepare for an ASCA accreditation review with controlled scope, valid test methods, complete records, and submission-ready laboratory reports for FDA.
- [Medical Device Standards Selection Guide](https://sigmascientific.us/insights/medical-device-standards-selection-guide/): Use this medical device standards selection guide to map device risks, claims, and markets to the right ISO and IEC testing requirements during planning.
- [How to Prepare an FDA ASCA Submission Correctly](https://sigmascientific.us/insights/prepare-fda-asca-submission/): Learn how to prepare an FDA ASCA submission with accredited test reports, correct consensus standards, and documentation that supports clear FDA review.
- [IEC Testing Turnaround Times for Medical Devices](https://sigmascientific.us/insights/iec-testing-turnaround-times-medical-devices/): IEC testing turnaround times depend on device risk, test scope, samples, and documentation. Plan earlier to protect medical device submission schedules.
- [How to Set Device Acceptance Criteria Correctly](https://sigmascientific.us/insights/how-to-set-device-acceptance-criteria-correctly/): Learn how to set device acceptance criteria that connect user needs, risk controls, test methods, and objective evidence for medical device submissions.
- [What Devices Need ASCA Testing for FDA Submissions?](https://sigmascientific.us/insights/what-devices-need-asca-testing/): Learn what devices need ASCA testing, when FDA may rely on accredited laboratory reports, and how to define a practical, standards-based test plan early.
- [How to Test Dielectric Strength in Medical Devices](https://sigmascientific.us/insights/how-to-test-dielectric-strength-medical-devices/): Learn how to test dielectric strength in medical devices using controlled withstand-voltage methods, documented results, and applicable IEC requirements.
- [How to Reduce Medical Device Test Failures](https://sigmascientific.us/insights/reduce-medical-device-test-failures/): Learn how to reduce medical device test failures through earlier standards planning, representative samples, clear protocols, and submission-ready evidence.
- [How to Plan an IEC 60601 Test Strategy Early](https://sigmascientific.us/insights/plan-iec-60601-test-strategy/): Plan an IEC 60601 test strategy that aligns risk management, applicable collateral standards, device configurations, and evidence for regulatory review.
- [ASCA Testing Versus Traditional Testing for Devices](https://sigmascientific.us/insights/asca-testing-versus-traditional-testing/): Compare ASCA testing versus traditional testing for medical devices, including FDA recognition, scope, documentation, timing, and submission needs today.
- [Medical Device Verification Testing Services](https://sigmascientific.us/insights/medical-device-verification-testing-services/): Medical device verification testing services generate accredited safety and performance evidence for submission-ready, standards-based device development.
- [In House vs Accredited Testing for Medical Devices](https://sigmascientific.us/insights/in-house-vs-accredited-testing-medical-devices/): Compare in house vs accredited testing for medical devices, including data credibility, ISO/IEC 17025 controls, FDA submissions, and development speed.
- [FDA Recognized Consensus Standards Guide](https://sigmascientific.us/insights/fda-recognized-consensus-standards-guide/): Use this FDA recognized consensus standards guide to select applicable standards, build defensible test evidence, and prepare a focused FDA submission.
- [How to Prepare an ASCA Submission for FDA Review](https://sigmascientific.us/insights/how-to-prepare-asca-submission/): Learn how to prepare an ASCA submission with eligible standards, accredited testing, complete reports, and clear FDA-ready documentation for efficient review.
- [Verification vs Validation in Medical Devices](https://sigmascientific.us/insights/verification-vs-validation-medical-devices/): Verification vs validation medical devices: clarify the evidence each requires, when testing applies, and how to plan design controls for submissions.
- [Choosing an FDA Submission Testing Laboratory](https://sigmascientific.us/insights/fda-submission-testing-laboratory/): Select an FDA submission testing laboratory with the accreditation, scope, methods, and reporting discipline needed to support a defensible device filing.
- [What an ISO 17025 Medical Laboratory Proves](https://sigmascientific.us/insights/iso-17025-medical-laboratory/): See how an ISO 17025 medical laboratory supports defensible medical device test data, accreditation scope review, and regulatory submission readiness.
- [Why Use Third Party Testing for Medical Devices?](https://sigmascientific.us/insights/why-use-third-party-testing-medical-devices/): Why use third party testing for medical devices? Independent, accredited evidence supports safety, performance, and regulatory submission confidence.
- [Guide to Electrical Safety Compliance for Devices](https://sigmascientific.us/insights/guide-to-electrical-safety-compliance/): A guide to electrical safety compliance for medical devices, covering risk-based design, IEC 60601-1 testing, documentation, and laboratory readiness.
- [How to Qualify Endoscope Performance Properly](https://sigmascientific.us/insights/how-to-qualify-endoscope-performance/): Learn how to qualify endoscope performance with risk-based protocols, documented acceptance criteria, and standards-aligned evidence for regulatory review.
- [Choosing an IEC 60601 Testing Laboratory](https://sigmascientific.us/insights/iec-60601-testing-laboratory/): Select an IEC 60601 testing laboratory with accredited methods, defined scope, and documentation supporting medical device regulatory submissions directly.
- [Regulatory Submission Testing Support That Holds Up](https://sigmascientific.us/insights/regulatory-submission-testing-support/): Regulatory submission testing support for medical devices: accredited evidence, standards-based reports, and planning that protects regulatory timelines.
- [How to Validate Ultrasound Output for Compliance](https://sigmascientific.us/insights/how-to-validate-ultrasound-output/): Learn how to validate ultrasound output with traceable acoustic measurements, protocols, and documentation that supports device compliance submissions.
- [A Practical Guide to Human Factors Testing](https://sigmascientific.us/insights/guide-to-human-factors-testing/): This guide to human factors testing explains planning, formative studies, validation, and documentation for medical device regulatory submission teams.
- [Medical Acoustic Output Testing for Safer Devices](https://sigmascientific.us/insights/medical-acoustic-output-testing/): Medical acoustic output testing provides the measured data needed to verify device safety, performance, and compliance for regulatory submission review.
- [FDA ASCA Accredited Lab for Device Testing](https://sigmascientific.us/insights/fda-asca-accredited-lab-device-testing/): Learn how an FDA ASCA accredited lab supports medical device testing, standards-based reports, and efficient FDA submission preparation for global manufacturers.
- [Diagnostic Ultrasound Performance Testing](https://sigmascientific.us/insights/diagnostic-ultrasound-performance-testing/): Diagnostic ultrasound performance testing verifies acoustic output, image quality, and controls with standards-based evidence for regulatory submissions.
- [Medical Device Testing Services That Matter](https://sigmascientific.us/insights/medical-device-testing-services-that-matter/): Medical device testing services support safety, performance, and regulatory readiness through accredited evaluations aligned with ISO, IEC, and FDA.
- [How to Choose the Best Medical Device Testing Labs](https://sigmascientific.us/insights/best-medical-device-testing-labs/): How to evaluate the best medical device testing labs for accreditation, standards scope, turnaround, documentation, and regulatory confidence.
- [Medical Device Compliance Testing Quote](https://sigmascientific.us/insights/medical-device-compliance-testing-quote/): Need a medical device compliance testing quote? Learn what drives scope, timing, cost, and documentation for standards-based lab testing.
- [Physiotherapy Equipment Compliance Testing](https://sigmascientific.us/insights/physiotherapy-equipment-compliance-testing/): Physiotherapy equipment compliance testing verifies safety, performance, and standards alignment for devices facing regulatory review and market entry.
- [ECG Device Safety Testing Requirements](https://sigmascientific.us/insights/ecg-device-safety-testing-requirements/): ECG device safety testing verifies electrical safety, essential performance, and regulatory readiness for monitors, recorders, and diagnostic systems.
- [Patient Monitor Testing Requirements](https://sigmascientific.us/insights/patient-monitor-testing-requirements/): Patient monitor testing requirements cover safety, EMC, performance, software, and usability evidence needed for regulatory review and release.
- [Catheter Testing Services That Support Compliance](https://sigmascientific.us/insights/catheter-testing-services-compliance/): Catheter testing services help verify safety, performance, and compliance through standards-based data for regulatory submissions and design validation.
- [Endoscope Performance Testing Lab Criteria](https://sigmascientific.us/insights/endoscope-performance-testing-lab-criteria/): Choose an endoscope performance testing lab with ISO/IEC 17025 accreditation, standards-based methods, and documentation built for regulatory review.
- [Human Factors Validation for Medical Devices](https://sigmascientific.us/insights/human-factors-validation-medical-devices/): Human factors validation medical devices teams can trust starts with realistic use scenarios, defined users, and defensible test evidence.
- [Acoustic Output Measurement Medical Devices](https://sigmascientific.us/insights/acoustic-output-measurement-medical-devices/): Acoustic output measurement medical devices need accurate, standards-based testing to support safety, performance claims, and regulatory submissions.
- [ISO 17025 Compliance for Medical Devices: A Complete Guide](https://sigmascientific.us/insights/iso-17025-compliance-medical-devices/): Learn how to achieve ISO 17025 compliance for medical device testing. Step-by-step implementation roadmap, audit requirements, and regulatory alignment.
- [ISO 17025 Accredited Laboratory: Complete Guide](https://sigmascientific.us/insights/iso-17025-accredited-laboratory-guide/): Learn what ISO 17025 accreditation means, why it matters for testing labs, and how to find accredited laboratories. Discover requirements and benefits.
- [Ultrasound Transducer Performance Testing](https://sigmascientific.us/insights/ultrasound-transducer-performance-testing/): Ultrasound transducer performance testing verifies acoustic output, image quality, and safety data needed for compliance, validation, and submissions.
- [Diagnostic Ultrasound Output Testing Explained](https://sigmascientific.us/insights/diagnostic-ultrasound-output-testing-explained/): Diagnostic ultrasound output testing verifies acoustic output, exposure indices, and compliance data for safe, standards-based device submissions.
- [Dielectric Strength Testing Medical Devices](https://sigmascientific.us/insights/dielectric-strength-testing-medical-devices/): Dielectric strength testing medical devices verifies insulation integrity under high voltage, supporting IEC compliance, risk control, and safety data.
- [IEC 60601 Electrical Safety Testing Explained](https://sigmascientific.us/insights/iec-60601-electrical-safety-testing/): IEC 60601 electrical safety testing verifies leakage, grounding, insulation, and risk controls for compliant medical device market entry.
- [ISO 17025 Medical Device Lab Requirements](https://sigmascientific.us/insights/iso-17025-medical-device-lab-requirements/): Learn what an iso 17025 medical device lab must demonstrate in scope, methods, traceability, and reporting to support regulatory-ready test data.
- [ASCA Accredited Medical Device Testing](https://sigmascientific.us/insights/asca-accredited-medical-device-testing/): ASCA accredited medical device testing helps manufacturers generate recognized safety data, reduce review friction, and support faster submissions.
- [Medical Device Performance Testing Services](https://sigmascientific.us/insights/medical-device-performance-testing-services/): Medical device performance testing services support compliance, safety, and submission readiness with standards-based data from accredited labs.
- [Choosing a Medical Device Safety Testing Lab](https://sigmascientific.us/insights/choosing-medical-device-safety-testing-lab/): How to choose a medical device safety testing lab with the right accreditation, standards scope, and documentation for faster regulatory review.

## Pages

- [Start a project](https://sigmascientific.us/start-a-project/): FDA ASCA accredited laboratory TL-114 11 standards in our ASCA scope, plus A2LA ISO/IEC 17025 accreditation 4896.01.
- [Standards finder](https://sigmascientific.us/resources/standards-finder/): FDA ASCA accredited laboratory TL-114 11 standards in our ASCA scope, plus A2LA ISO/IEC 17025 accreditation 4896.01.
- [FAQs](https://sigmascientific.us/resources/faq/): FDA ASCA accredited laboratory TL-114 11 standards in our ASCA scope, plus A2LA ISO/IEC 17025 accreditation 4896.01.
- [ASCA Program Guide](https://sigmascientific.us/resources/asca-guide/): FDA ASCA accredited laboratory TL-114 11 standards in our ASCA scope, plus A2LA ISO/IEC 17025 accreditation 4896.01.
- [Resources](https://sigmascientific.us/resources/)
- [Measurements](https://sigmascientific.us/measurements/): FDA ASCA accredited laboratory TL-114 11 standards in our ASCA scope, plus A2LA ISO/IEC 17025 accreditation 4896.01.
- [Contact](https://sigmascientific.us/contact/): FDA ASCA accredited laboratory TL-114 11 standards in our ASCA scope, plus A2LA ISO/IEC 17025 accreditation 4896.01.
- [About Us](https://sigmascientific.us/about/): FDA ASCA accredited laboratory TL-114 11 standards in our ASCA scope, plus A2LA ISO/IEC 17025 accreditation 4896.01.
- [Accreditations](https://sigmascientific.us/accreditations/): Sigma Scientific Services is an FDA ASCA accredited testing laboratory (TL-114) and is accredited by A2LA to ISO/IEC 17025:2017 (4896.01). See the 11 standards in our ASCA scope.
- [Services](https://sigmascientific.us/services/): FDA ASCA accredited testing of medical electrical equipment and ultrasound systems, plus engineering tests for endoscope optics and ultrasound materials.
- [Ultrasound Gel & Materials Testing](https://sigmascientific.us/services/ultrasound-gel-testing/): Acoustic and physical testing of ultrasound coupling gels and probe covers, from speed of sound and attenuation to viscosity and pH. Engineering testing with Sigma in-house methods, outside our accreditation scope.
- [Endoscope Optical Performance Testing](https://sigmascientific.us/services/endoscope-optical-testing/): Optical performance testing of rigid and flexible endoscopes to the ISO 8600 series, from field of view and resolution to color and latency. Engineering testing with Sigma in-house methods, outside our accreditation scope.
- [Home Healthcare Equipment Testing](https://sigmascientific.us/services/home-healthcare-equipment-testing/): Testing of medical electrical equipment used in the home healthcare environment to IEC 60601-1-11, from environmental conditions to lay operators, with an ASCA summary test report for your FDA 510(k).
- [Alarm Systems Testing](https://sigmascientific.us/services/alarm-systems-testing/): Testing of alarm systems in medical electrical equipment to IEC 60601-1-8, from alarm priorities to auditory and visual alarm signals, with an ASCA summary test report for your FDA 510(k).
- [Infant Incubator Testing](https://sigmascientific.us/services/infant-incubator-testing/): Basic safety and essential performance testing of infant incubators and infant transport incubators to IEC 60601-2-19 and IEC 60601-2-20, with an ASCA summary test report for your FDA 510(k).
- [HITU Testing](https://sigmascientific.us/services/hitu-testing/): Basic safety and essential performance testing of high intensity therapeutic ultrasound equipment to IEC 60601-2-62, with acoustic power and focal field measurements and an ASCA summary test report for your FDA submission.
- [Endoscope Safety Testing](https://sigmascientific.us/services/endoscope-safety-testing/): Basic safety and essential performance testing of endoscopic equipment to IEC 60601-2-18, from endoscopes to camera heads and light sources, with an ASCA summary test report for your FDA 510(k).
- [Physiotherapy Ultrasound Testing](https://sigmascientific.us/services/physiotherapy-ultrasound-testing/): Basic safety and essential performance testing of ultrasonic physiotherapy equipment to IEC 60601-2-5, with field measurements to IEC 61689 and an ASCA summary test report for your FDA 510(k).
- [Usability & Human Factors Testing](https://sigmascientific.us/services/usability-human-factors/): Evaluation of your usability engineering process and file to IEC 60601-1-6 and IEC 62366-1, with an ASCA summary test report for your FDA 510(k).
- [Electrical Safety Testing](https://sigmascientific.us/services/electrical-safety-testing/): Basic safety and essential performance testing to IEC 60601-1 and ANSI/AAMI ES60601-1, with an ASCA summary test report for your FDA 510(k).
- [Insights](https://sigmascientific.us/insights/): Practical guidance from Sigma Scientific engineers on acoustic output, electrical safety, FDA ASCA and medical device testing.
- [Ultrasound Acoustic Output Testing](https://sigmascientific.us/services/ultrasound-acoustic-output-testing/): FDA ASCA-accredited acoustic output measurement for diagnostic ultrasound systems and transducers: IEC 60601-2-37, IEC 62127-1 and IEC 62359. Submission-ready reports. Quote in 24 hours.
- [Home](https://sigmascientific.us/): FDA ASCA accredited laboratory TL-114 11 standards in our ASCA scope, plus A2LA ISO/IEC 17025 accreditation 4896.01.


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