PrintMake sure you are prepared for your Japan medical device registration by fully understanding the QMS auditing process. Audits can either consist of a document review or an on-site inspection. This webcast CD will describe how to prepare for your audit and what the process entails. This 90-minute session will include a 60-minute presentation, followed by 30 minutes of Q&A.
See a sample page of our webcast presentation.
The following topics are covered in this webcast:
- What is a Japanese QMS audit?
- Preparing for an audit (appropriate paperwork, documents, etc)
- Specialized applications depending on the medical device type (disposable consumables, implantables, radiological medical devices, etc.)
- ISO vs. QMS
- Device Master Record
- QMS Inspection Types
- Pre-approval compliance
- Post-approval compliance
- Compliance inspection for exporting medical devices
- Which government agency/regulatory authority will conduct the audit?
- On-site versus document review?
- What items will be reviewed
- Inspection process
- Best ways to prepare for audit (tips for success)
- How to respond to problems
This webcast is designed for medical device professionals in regulatory affairs, business development, international sales and marketing, and anyone who wants to be current on Japanese medical device regulatory issues.