Medical Resources

Want more? Browse through our latest Medical resources and stay up to date with industry trends, changing standards and market opportunities.

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

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

In Vitro Diagnostic Medical Equipment Overview - Fact Sheet

Risk Management in 61010-1, Third Edition - White Paper

61010-1, 3rd Edition Tip sheet - Fact Sheet

Standard Overview: 61010-1, Third Edition - Webinar

NSF 456 Vaccine Storage - Fact Sheet

Regulatory - US / FDA

FDA ASCA Program Q&A - Fact Sheet

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

FDA ASCA Program November 2023 Updates - Webinar

5 Essential Steps To Medical Device Certification - White Paper

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

Regulatory - Europe / UK

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

Differences between the EU MDD and the MDR - FAQ

UKCA Requirements For Medical Devices - Webinar

UKCA Mandatory Marking Guidance Document - White Paper

Brexit changes to the European Medical Devices Market - Fact Sheet

Regulatory - Global

Unique Device Identification (UDI) - Webinar

NMPA Self-Testing Manufacturer Process - Fact Sheet

Requirements for China NMPA Registration - Webinar

China NMPA Requirements For Self-Testing - Fact Sheet

Medical Device Market Requirements for Japan - White Paper

Medical Device Market Requirements for Brazil - White Paper

G Marking For Low-Voltage Electrical Products in the Middle East - White Paper

Advanced Technologies

Artificial Intelligence and Machine Learning in Medical Devices: Fact Sheet | Webinar

Evolution of Healthcare and Home Health Devices - Webinar

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

Testing & Compliance Requirements For Robotic Medical Devices - FAQ White Paper

Functional Safety: Understanding Safety Integrity Levels - Poster

Active Implantable Medical Devices - White Paper

Medical Electrical Equipment used in the Home Healthcare Environment - White Paper

Medical Robots - Fact Sheet

Medical IoT & Connected Technologies

Software As A Medical Device (SaMD): Webinar | Fact Sheet | FAQ Sheet

Medical OEM Wireless Coexistence Testing - Webinar

Evolution of Cyber Threat Modeling in Risk Management - White Paper

Wireless Coexistence Medical Devices - FAQs

Medical Devices Cybersecurity Q&A - Fact Sheet

Cybersecurity in Medical Devices Top 10 FAQ - Fact Sheet

FDA Cybersecurity in Medical Devices - Webinar

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

IEC 62304 Medical Device Software Life Cycle Processes - Fact Sheet

Radio Equipment Directive (RED) - White Paper

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

Intertek Cybersecurity Guidelines per FDA Guidance - White Paper

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

Chemical Analysis for Biocompatibility Assessment of Medical Devices Draft Guidance for Industry - Q&A

Biocompatibility Risk Assessment and Evaluation Plans - White Paper

ISO 18562 and Biocompatibility - Webinar

IEC 62133 and the Lithium-ion Battery Compliance Roadmap - Webinar

Accelerated Stress Testing (AST) - White Paper

Battery Compliance: Testing Requirements for Medical Devices - White Paper

UN38.3 and the Requirements for the Transportation of Lithium Batteries - Webinar

Updates to Battery Certification: Options for Medical Devices - Webinar

Accelerated Stress Testing (AST) - Webinar

Accelerated Stress Testing to Manage Disruptive Market Changes - Webinar

Sustainability

ENERGY STAR® Requirements for Medical Imaging Equipment - Fact Sheet

Sustainable Innovation in Medical Device Manufacturing - Q&A

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

Five Key Factors Driving RoHS Compliance of Medical Electronics - White Paper

More Resources

Preliminary Design Review for Medical Devices- Fact Sheet

SATELLITE™ Client Test Program for Medical Devices - Fact Sheet

Ensuring a Smooth Path to Certification - Q&A

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

Medical Industry Outlook and Global Trends - Webinar

Design A Medical Device Right The First Time - Webinar

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