Single-Use Endoscopes: Critical Safety and Regulatory Considerations for Manufacturers

The transmission of infections via endoscopy remains a critical concern due to the inherent design challenges of scopes. Single-use endoscopes offer a pivotal solution by eliminating the risk of patient-to-patient contamination. However, manufacturers face key safety considerations in bringing these products to market for medical use. This webinar will discuss laboratory testing and terminal sterilization considerations and steps to help ensure compliance with regulatory requirements within the US and EU. Key topics will include:
Product and packaging design
Material compatibility with sterilization modalities
Microbiological testing and process validation considerations to ensure a desired sterility assurance level is met
Regulatory compliance, including compliance with ISO 13485 and adherence to the requirements of US and EU regulatory agencies