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.
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
Download the latest information from our medical device compliance experts
Creation of IEC 60601-1 4th Edition
IEC 60601-1-2 Ed. 4.1 Overview of Requirements
Medical OEM Wireless Coexistence Testing
Artificial Intelligence (AI) and Machine Learning (ML) in Medical Devices
Biocompatibility Risk Assessment and Evaluation Plans
For more expert papers, recordings, and presentations, visit our Medical Resources hub.
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 Client Test Program
- Planning for Quality through Disruptions
- Intertek's world-class team of Medical Experts
** 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.
