Medical Resources

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

White Papers

Active Implantable Medical Devices

Product Listing & Marking Strategies

UAE ECAS Compliance: Manufacturer Guidance

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

Five Steps to Medical Device Commercialization in the United States

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

Transitioning to IEC 60601-1 Edition 3.1

Intertek Cybersecurity Guidelines per FDA Guidance

Radio Equipment Directive (RED)

Accelerated Stress Testing (AST)

Battery Compliance: Testing Requirements for Medical Devices

Home Healthcare 60601-1-11

Closing the Gap: Understanding the Software 510(k) Review Process

Five Key Factors Driving RoHS Compliance of Medical Electronics

Guide to Building a Successful 510(k) Submission

How To Get Your Medical Equipment Certified and Ready for Brazil

IEC 60601-1: The New Philosophy of the 3rd Edition

The Manufacturer's Guide to the Revised MDD

Medical Electrical Equipment used in the Home Healthcare Environment

Top 10 Reasons Medical Devices Fail Product Certification Testing the First Time

Wireless Power: Cutting the Cord is Today's Mobile World

Risk Management in 61010-1, Third Edition

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

For a complete listing of white papers, please see: http://www.intertek.com/knowledge-education/whitepapers/

 

Webinar Recordings

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

Final Countdown to IEC 60601-1-2 4th Edition EMC

Accelerated Stress Testing to Manage Disruptive Market Changes

Risk Analysis as an Innovation Tool

Advice for Managing July 2016 RoHs 2 Deadline

EMC 4th Edition RMF Requirements

Transitioning to IEC 60601-1 Amendment 1

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

Managing Cybersecurity Risk in Connected Medical Devices

Updates to Battery Certification: Options for Medical Devices

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

Russia & Brazil: Regulatory Changes & Market Access

Accelerated Stress Testing (AST)

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

60601-1 3rd Edition Risk Management Requirements

ISO 14971 Series

Amendment 1, Simplified

Converting a Legacy Device to Wireless

Home Healthcare, 60601-1-11 Series Review

ISO 13485 Certification: How To Comply With the MDD

Pitfalls & Best Practices for Risk Management, 60601-1, Third Edition

Six Steps to Access New Markets

Standard Overview: 61010-1, Third Edition

Healthcare Anywhere 60601-1-11

Six Steps to Access Global Medical Device Markets: BRIC + Japan

Converting a Legacy Device to a Wireless Medical Device

IEC 60601-1-2 4th Edition EMC

For a complete listing of webinars, please see: http://www.intertek.com/knowledge-education/webinars/

 

Service Brochures & Toolkits

Medical Robots Fact Sheet

Cyber Security Assurance Safeguarding Patient Data

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

Human Factors for FDA Compliance FAQ

Russia and Brazil Regulatory Changes & Market Access FAQ

IEC 62133, 2nd Edition Tipsheet

61010-1, 3rd Edition Tipsheet

60601-1-11 Home Healthcare Checklist (Excel)

60601-1, 3rd Edition Toolkit (Zip File)

 

Video

An insider’s look at Intertek’s medical testing capabilities (Video)

RoHS 2 Training Video Parts 1 | 2 | 3 (Video)

For a complete listing of videos, please see http://www.intertek.com/video/

 

Blog

Planning Ahead for IEC 60601-1-2 4th Edition for Medical EMC

Top Failures With Mobile Health Apps

Risky Business: Toxicological Risk Assessments to Support Product Safety

For more relevant blogs please see: www.intertek.com/blog/medical-devices/

 

Customer Success Stories

Donald Fickett from Neurologica Corporation (Video)

Success Story: TransMotion Medical (Video) Case Study

 

Media Clips

Journal of Medical Device Regulation - How will the European Directive ‘RoHS 2’ Impact the Medical device industry?