Medical Resources

Safety Standards (60601-1)

Creation of IEC 60601-1 4th Edition- Webinar

Common Errors with the Application of IEC 60601-1 - Webinar

IEC 60601-1-8 AMD2 for Medical Alarms - Webinar

IEC 60601-1 3rd Edition, 2nd Amendment - Fact Sheet

Transitioning to IEC 60601-1 Edition 3.1 - White Paper

Transitioning to IEC 60601-1 Edition 3.1 - Webinar

Product Listing & Marking Strategies - White Paper

EMC Standards (60601-1-2)

IEC TS 60601-4-2 - Webinar

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

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

EMC 4th Edition RMF Requirements - Webinar

IEC 60601-1-2 EMC 4th Edition - Understanding the Requirements - Webinar

IEC 60601-1-2 4th Edition EMC - Webinar

Overview of ETSI EN 300 328 V2.2.2 - Webinar

Lab Equipment Standards

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

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

Regulatory - US / FDA

FDA ASCA Program Q&A

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

FDA ASCA Pilot Program November 2023 Updates - Webinar

5 Essential Steps To Medical Device Certification - White Paper

FDA ASCA Pilot Program Overview - Webinar

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

How to Integrate Human Factors in the Development Process for FDA Compliance - Webinar

Human Factors for FDA Compliance FAQ - Fact Sheet

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

The Manufacturer's Guide to the Revised MDD - White Paper

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

INMETRO Ordinance No. 384/2020 - Fact Sheet

How To Get Your Medical Equipment Certified and Ready for Brazil - White Paper

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

Six Steps to Access New Markets - Webinar

Advanced Technologies

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

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

Healthcare Anywhere 60601-1-11 - Webinar

Connected Technologies

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)

Biocompatibility Risk Assessment and Evaluation Plans - white paper

ISO 18562 and Biocompatibility - Webinar

Scientific Support Services for the Medical Device Industry - fact sheet

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

Ensure Your Products and Packaging are Free of Harmful Compounds with Extractables and Leachables Studies - Fact Sheet

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

Sustainable Innovation in Medical Device Manufacturing - Q&A

Medical Industry Outlook and Global Trends - Webinar

Overview of Product Certification - Webinar

Design A Medical Device Right The First Time - Webinar

Protek Featured Service: Facility Health Management - Fact Sheet

Germicidal Lighting - Fact Sheet

UAE ECAS Compliance: Manufacturer Guidance - White Paper

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

ISO 14971 Series - Webinar

Ventilator Production: Introductory Guide to Regulatory Requirements - Fact Sheet

NSF 456 Vaccine Storage - Fact Sheet