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Safety Standards (60601-1)

Ensuring Safety in Electrically Powered Patient Lifts | White Paper

Ensuring Safety in Electrically Powered Patient Lifts | White Paper

Patient Monitor Compliance: Standards and Evaluation | White Paper

Patient Monitor Compliance: Standards and Evaluation | White Paper

High Frequency Surgical Equipment and Accessories fact sheet

High Frequency Surgical Equipment and Accessories | Fact Sheet

Creation of IEC 60601-1 4th Edition webinar

Creation of IEC 60601-1 4th Edition

EMC Standards (60601-1-2)

Medical EMC In-Situ Testing: Complex EMC Testing in the Real World | White Paper

Medical EMC In-Situ Testing: Complex EMC Testing in the Real World | White Paper

In-Situ and Manufacturer Location EMC Testing | On-Demand Webinar

In-Situ and Manufacturer Location EMC Testing | On-Demand Webinar

IEC TS 60601-4-2 and EMC Guidance for Medical Devices | Fact Sheet

IEC TS 60601-4-2 and EMC Guidance for Medical Devices | Fact Sheet

On-Demand Medical EMC webinar: “IEC TS 60601-4-2”

Medical EMC webinar: “IEC TS 60601-4-2”

Lab Equipment Standards

Webinar: EN IEC 61010-2-101:2022 + A11:2022 Updates | On-demand Webinar

Webinar: EN IEC 61010-2-101:2022 + A11:2022 Updates | On-demand Webinar

IEC 61010-2-130 Lab Equipment Used By Children | Webinar

IEC 61010-2-130 Lab Equipment Used By Children | On-demand Webinar

IEC 61010-2-130 for Lab Equipment in Schools | Fact Sheet

IEC 61010 Series: Master the Challenge & Keep Up with the Changes | White Paper

IEC 61010 Series: Master the Challenge & Keep Up with the Changes | White Paper

Regulatory - US / FDA

Understand Your FDA Regulatory Obligations – White Paper

Understand Your FDA Regulatory Obligations – Download the Free White Paper

FDA ASCA Program Q&A | Information Sheet

FDA ASCA Program Q&A | Information Sheet

FDA 510(K) Compliance To Ensure A Successful Submission | FAQ Sheet

FDA 510(K) Compliance To Ensure A Successful Submission | FAQ Sheet

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On-Demand Webinar: November 2023 FDA ASCA Program Updates

Regulatory - Europe / UK

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Webinar: Changes From Medical Device Directive (MDD) to Medical Device Regulation (MDR)

Differences between the EU MDD and the MDR | FAQ

Differences between the EU MDD and the MDR | FAQ

On-Demand Webinar: "UKCA Requirements For Medical Devices"

UKCA Mandatory Marking Guidance | White Paper

UKCA Mandatory Marking Guidance | White Paper

Regulatory - Global

CB Scheme for Medical Devices | Fact Sheet

CB Scheme for Medical Devices | Fact Sheet

Intertek NMPA Self-Testing Manufacturer Process flowchart

Intertek NMPA Self-Testing Manufacturer Process

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On-Demand Webinar: "Requirements for China NMPA Registration"

China NMPA Requirements For Self-Testing | Fact Sheet

China NMPA Requirements For Self-Testing | Fact Sheet

Advanced Technologies

Total Quality Assurance of Medical Robots/Robotics | Fact Sheet

Total Quality Assurance of Medical Robots/Robotics | Fact Sheet

AI-Enabled Medical Device Development | FAQ Paper

AI-Enabled Medical Device Development | FAQ Paper

Artificial Intelligence (AI) and Machine Learning (ML) in medical devices fact sheet

Artificial Intelligence (AI) and Machine Learning (ML) in Medical Devices | Fact Sheet

Machine Learning and Artificial Intelligence Transforming Healthcare with Advanced Technologies | Webinar

Machine Learning and Artificial Intelligence Transforming Healthcare with Advanced Technologies | Webinar

Medical IoT & Connected Technologies

Medical Wearables Testing & Certification | Fact Sheet

Medical Wearables Testing & Certification | Fact Sheet

Medical Wearables Testing and Certification | FAQ Download

Medical Wearables Testing and Certification | FAQ Download

Artificial Intelligence Assessment for Medical Devices | Brochure

Artificial Intelligence Assessment for Medical Devices | Brochure

Medical OEM Wireless Coexistence Testing webinar

Medical OEM Wireless Coexistence Testing

Performance Testing (Battery, Packaging, Materials, and More)

Accelerated Stress Testing for Medical Devices | Fact Sheet

Accelerated Stress Testing for Medical Devices | Fact Sheet

Accelerated Stress Testing | White Paper

Accelerated Stress Testing | White Paper

Ventilator face mask and breathing tube worn by a patient in a hospital bed.

FDA Guidance: Chemical Analysis for Biocompatibility Assessment of Medical Devices Draft Guidance for Industry

Biocompatibility Risk Assessment and Evaluation Plans white paper

Biocompatibility Risk Assessment and Evaluation Plans

Home Healthcare

On-Demand Medical Webinar: "Evolution of Healthcare and Home Health Devices"

Evolution of the Home Healthcare Market and Medical Device Compliance | White Paper

Evolution of the Home Healthcare Market and Medical Device Compliance | White Paper

Medical Electrical Equipment for the Home Healthcare Environment | White Paper

Medical Electrical Equipment for the Home Healthcare Environment | White Paper

Home Healthcare Medical Devices | FAQ

Home Healthcare Medical Devices | FAQ

Cybersecurity

ISO/IEC 81001-5-1 Cybersecurity for Medical Devices | Fact Sheet

ISO/IEC 81001-5-1 Cybersecurity for Medical Devices | Fact Sheet

IEC 81001-5-1 and Cybersecurity for Medical Devices | On-Demand Webinar

IEC 81001-5-1 and Cybersecurity for Medical Devices | On-Demand Webinar

Top 10 FAQs regarding Cybersecurity in Medical Devices | FAQ

Top 10 FAQs regarding Cybersecurity in Medical Devices | FAQ

Cyber Threat Modeling White Paper from Intertek

Download Our Guide to Cyber Threat Modeling

Software and Software as a Medical Device (SaMD)

IEC 62304 Medical Device Software Life Cycle Processes FAQ Sheet

IEC 62304 Medical Device Software Life Cycle Processes | FAQ Sheet

Software As a Medical Device Compliance Requirements | Webinar

Software as a Medical Device (SaMD) | Fact Sheet

Software As A Medical Device (SaMD) | FAQ Sheet

Software As A Medical Device (SaMD) | FAQ Sheet

Sustainability

Life Cycle Assessment for Medical Devices | Webinar

Life Cycle Assessments for Medical Devices | On-Demand Webinar

ENERGY STAR® Requirements for Medical Imaging Equipment fact sheet

ENERGY STAR® Requirements for Medical Imaging Equipment | Fact Sheet

Sustainable Innovation in Medical Device Manufacturing | FAQ

Sustainable Innovation in Medical Device Manufacturing | FAQ

Additional Resources

Preliminary Design Review for Medical Devices fact sheet

Preliminary Design Review for Medical Devices | Fact Sheet

SATELLITE™ Client Test Program for Medical Devices fact sheet

SATELLITE™ Client Test Program for Medical Devices

Medical Devices Q&A: Ensuring a Smooth Path to Certification

Medical Devices Q&A: Ensuring a Smooth Path to Certification

Compliance 101: Ten Common Questions About Product Compliance | White Paper

Compliance 101: Ten Common Questions About Product Compliance | White Paper

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