Want more? Browse through our latest Medical resources and stay up to date with industry trends, changing standards and market opportunities.
Safety Standards (60601-1)
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 (60601-2)
IEC TR 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
Regulatory - US / FDA
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
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
Wireless Coexistence For Medical Devices - Webinar
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
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