Introduction to Regulatory Requirements
As manufacturers quickly pivot and retool operations to produce medical equipment and supplies, Intertek has mobilized our global workforce and operational capacity to support customers in understanding quality and safety compliance as they develop products for medical use.
Companies are facing unique challenges as they work to understand the regulatory requirements for life-saving medical equipment such as ventilators and respirators. We have consolidated some of the most important information into a Production Guide for Ventilators, providing a high-level overview of very complex global requirements.
DOWNLOAD VENTILATOR PRODUCTION GUIDE
Topics covered include:
- Manufacturing requirements
- Ventilator testing for safety and performance
- Product labelling requirements
- Product registration and authorization process
- Packaging and shipping requirements
- Facility and environmental sterilization requirements & inspections
- Supply chain quality and continuity
- Training programs and tools
Contact Intertek for immediate help or visit our Novel Coronavirus Resources page to learn more about all of the services and resources available to support the global community.
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
Related Links
Total Quality Assurance during Novel Coronavirus
Intertek provides mission-critical quality assurance solutions to ensure production and operations continue to function smoothly in rapidly changing situations. Intertek’s first priority is always health and safety while delivering outstanding service to our customers.
IEC 60601-1-2 Edition 4
Learn about dramatic changes including more robust risk analysis requirements of 4th Edition. Download the white paper.