Medical Resources

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

White Papers

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

Five Steps to Medical Device Commercialization in the United States (PDF)

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

Transitioning to IEC 60601-1 Edition 3.1 (PDF)

Intertek Cybersecurity Guidelines per FDA Guidance (PDF)

Radio Equipment Directive (RED) (PDF)

Accelerated Stress Testing (AST) (PDF)

Battery Compliance: Testing Requirements for Medical Devices (PDF)

Home Healthcare 60601-1-11 (PDF)

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

Five Key Factors Driving RoHS Compliance of Medical Electronics (PDF)

Guide to Building a Successful 510(k) Submission (PDF)

How To Get Your Medical Equipment Certified and Ready for Brazil (PDF)

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

The Manufacturer's Guide to the Revised MDD (PDF)

Medical Electrical Equipment used in the Home Healthcare Environment (PDF)

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

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

Risk Management in 61010-1, Third Edition (PDF)

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

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

 

Webinar Recordings

Accelerated Stress Testing to Manage Disruptive Market Changes (Recording)

Risk Analysis as an Innovation Tool (Recording)

Advice for Managing July 2016 RoHs 2 Deadline (Recording)

EMC 4th Edition RMF Requirements (Recording)

Transitioning to IEC 60601-1 Amendment 1 (Recording)

UN38.3 and the Requirements for the Transportation of Lithium Batteries (Recording)

Managing Cybersecurity Risk in Connected Medical Devices (Recording)

Updates to Battery Certification: Options for Medical Devices (Recording)

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

Russia & Brazil: Regulatory Changes & Market Access (Recording)

Accelerated Stress Testing (AST) (Recording)

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

60601-1 3rd Edition Risk Management Requirements (Recording)

ISO 14971 Series (Recording)

Amendment 1, Simplified (Recording)

Converting a Legacy Device to Wireless (Recording)

Home Healthcare, 60601-1-11 Series Review (Recording)

ISO 13485 Certification: How To Comply With the MDD (Recording)

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

Six Steps to Access New Markets (Recording)

Standard Overview: 61010-1, Third Edition (Recording)

Healthcare Anywhere 60601-1-11 (Recording)

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

Converting a Legacy Device to a Wireless Medical Device (Recording)

IEC 60601-1-2 4th Edition EMC (Recording)

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

 

Service Brochures & Toolkits

Cyber Security Assurance Safeguarding Patient Data (PDF)

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

Human Factors for FDA Compliance FAQ (PDF)

Russia and Brazil Regulatory Changes & Market Access FAQ (PDF)

IEC 62133, 2nd Edition Tipsheet (PDF)

61010-1, 3rd Edition Tipsheet (PDF)

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 (PDF)

 

Media Clips

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

 

 

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