Testing and Certification for Electrical Safety and Electromagnetic Compatability (EMC)
To bring your medical device to North American, European and global markets with speed and efficiency, you need a testing and certification partner who knows your business. Count on Intertek for compliance testing and certification to harmonized global standards and requirements, all from a single source.
Medical Device Market Requirements Certification Guide
Brazil | Japan | China
IEC 60601: Product Safety Standards for Medical Devices
We offer end-to-end solutions from product development and risk management file review/documentation, to comprehensive testing to IEC 60601 series of standards.
IEC 60601-1-2: Medical Device EMC Testing
IEC 60601-1-2 Electromagnetic Compatibility (EMC) Testing for Medical Devices including IEC 60601-1-2 4th Edition Amendment 1.
The IECEE CB Scheme and Medical Devices
Intertek provides CB Scheme Certification issuing more CB certificates than any other National Certification body giving you access to global Medical Device markets
FDA ASCA Program
The FDA's ASCA Program is aimed at ensuring quality and accuracy in medical device pre-market submissions. Ultimately the goal is to help make the process more efficient and to add confidence in the levels of safety, performance, and quality assurance.
China NMPA Requirements for Medical Devices
Intertek can help you unlock market opportunities to export Medical Devices in the fast-growing China healthcare market with guidance on China NMPA Requirements.
Related Links
IEC 60601-1 3rd Ed., 2nd Amendment: An Overview
Confused by transition times and stringent testing expectations?Download the fact sheet.
Knowledge Center
Evolution of the Home Healthcare Market and Medical Device Compliance
White Paper | Webinar Recording
Ventilator Production: Introductory Guide to Regulatory Requirements
Critical Care Medical Devices: First-In-Queue Priority
Product Listing & Marking Strategies White Paper
IEC 60601-1-2 Edition 4 White Paper
Updated FCC Approval Process Webinar
Extractables and Leachables Studies Fact Sheet
Five Steps to Medical Device Commercialization in the United States White Paper
Making Green Profitable: Using IEC 60601-1-9 as a Competitive Advantage White Paper
Related Links
- ETL Mark The Industry's Fastest Certification Program
- Search and Buy Medical Device Standards
- Reese's Law – ANSI/UL 4200A-2023
- My Test Central
- Directories
- Certification Marks
- Global Research & Certification
- Medical Podcast - Compliance with Clarissa
- Satellite Data Acceptance Program
- Planning for Quality through Disruptions
- Intertek's world-class team of Medical Experts
- Intertek Protek - The world’s first industry-agnostic, end-to-end health, safety and wellbeing assurance program
*The Intertek legal entities that provide medical device management system certification services (including ISO 13485 and MDSAP) and Notified Body services (MDR 2017/745 and MDD 93/42/EEC) do not provide any consulting services. Clients who have used other Intertek legal entities’ consulting services are not eligible to receive management system certification services or Notified Body services from Intertek.
