Much attention has been paid to the regulatory requirements of reprocessing SINGLE use devices.
However, there is increasing attention being directed towards reprocessing REUSABLE medical devices and regulatory requirements. The purpose of this seminar is to explain the rationale, the legal requirements and some methods commonly used for reprocessing & validating reusable medical devices.
Why should you attend: Any firm reprocessing another manufacturer's medical device becomes the legal manufacturer with all the responsibilities for compliance, especially sterility. Failure to prove sterility in almost certainly a cause for either voluntary recall or FDA mandated recall. The same is true if you are reprocessing your own medical device. If intended to be re sterilized by the user facility, cleaning & sterilization instructions must be precise and validated.
Areas Covered in the Session:
Who Will Benefit:
- Reasoning behind labeling requirements
- Regulatory requirements
- Intended use & design
- Validating cleaning & sterilization
- Design Engineers
- QA Manager
- Quality Engineers
- Regulatory Affairs Manager
- Manufacturing Engineers