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