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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)

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”

IEC 60601-1-2 Ed. 4.1 Overview webinar

Medical Webinar: IEC 60601-1-2 Ed. 4.1 Overview of Requirements

IEC 60601-1-2 Edition 4: New Requirements for Medical EMC white paper

IEC 60601-1-2 Edition 4: New Requirements for Medical EMC | White Paper

Overview of ETSI EN 300 328 V2.2.2 | On-Demand Webinar

Overview of ETSI EN 300 328 V2.2.2 | On-Demand Webinar

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

In Vitro Diagnostic Medical Equipment Overview | Fact Sheet

In Vitro Diagnostic Medical Equipment Overview | Fact Sheet

Fact Sheet: NSF 456 Vaccine Storage

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

5 Essential Steps to Medical Device Certification | White Paper

5 Essential Steps to Medical Device Certification | A Guide for Start-up Companies

Five Steps to Medical Device Commercialization in the United States | White Paper

Five Steps to Medical Device Commercialization in the United States | White Paper

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

Brexit changes to the European Medical Devices Market | White Paper

Brexit changes to the European Medical Devices Market | White Paper

Regulatory - Global

CB Scheme for Medical Devices | Fact Sheet

CB Scheme for Medical Devices | Fact Sheet

IEC 60601-2-10 Edition 2.2 (2023) | FAQ Paper

IEC 60601-2-10 Edition 2.2 (2023) | FAQ Paper

Unique Device Identification (UDI) for Medical Devices webinar

Unique Device Identification (UDI) | On-Demand Webinar

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

Pharmaceutical and Medical Device Act (PMD Act) and Market Requirements for Japan guide

Pharmaceutical and Medical Device Act (PMD Act) and Market Requirements for Japan

Medical Device Market Requirements for Brazil guide

Medical Device Market Requirements for Brazil

G Marking For Low-Voltage Electrical Products in the Gulf Member States | White Paper

G Marking For Low-Voltage Electrical Products in the Gulf Member States | White Paper

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

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

Testing & Compliance Requirements For Robotic Medical Devices | FAQ

Testing & Compliance Requirements For Robotic Medical Devices | FAQ

Functional Safety: Understanding Safety Integrity Levels | Poster

Functional Safety: Understanding Safety Integrity Levels | Poster

Active Implantable Medical Devices | White Paper

Active Implantable Medical Devices | White Paper

Medical Electrical Equipment for the Home Healthcare Environment | White Paper

Medical Electrical Equipment for the Home Healthcare Environment | White Paper

Medical IoT & Connected Technologies

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

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

Top 10 FAQs regarding Cybersecurity in Medical Devices | FAQ

Top 10 FAQs regarding Cybersecurity in Medical Devices | FAQ

Home Healthcare Medical Devices | FAQ

Home Healthcare Medical Devices | FAQ

Six Compliance-Related Questions About Connected Home Healthcare Devices | White Paper

Six Compliance-Related Questions About Connected Home Healthcare Devices | White Paper

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

Medical OEM Wireless Coexistence Testing webinar

Medical OEM Wireless Coexistence Testing

Cyber Threat Modeling White Paper from Intertek

Download Our Guide to Cyber Threat Modeling

Wireless Coexistence Q&A

Download: Wireless Coexistence Q&A

Medical Devices Cybersecurity Q&A Fact Sheet

Download our Medical Devices Cybersecurity Q&A Fact Sheet

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FDA Cybersecurity in Medical Devices

Radio Equipment Directive (RED) update with Cybersecurity Requirements | FAQs

Radio Equipment Directive (RED) update with Cybersecurity Requirements | FAQs

Radio Equipment Directive (RED) 2014/53/EU white paper

Radio Equipment Directive (RED) 2014/53/EU | White Paper

Designed for Security: Mitigating Cyber Threats to Your Connected Medical Device | Webinar

Designed for Security: Mitigating Cyber Threats to Your Connected Medical Device | Webinar

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 (AST) | On-demand Webinar

Accelerated Stress Testing | White Paper

Accelerated Stress Testing | White Paper

Using Accelerated Stress Testing to Manage Disruptive Market Changes | Webinar

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

ISO 18562 and Biocompatibility webinar

ISO 18562 and Biocompatibility | On-Demand Webinar

IEC 62133 and the Lithium-ion Battery Compliance Roadmap

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

Making Green Profitable: Using IEC 60601-1-9 as a Competitive Advantage

More 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

On Demand Webinar: Medical Industry Outlook and Global Trends

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On-Demand Medical Webinar: "Design It Right The First Time"

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