This management review webinar is an example of the ISO 13485:2016 updated procedures and training webinars you can download from Medical Device Academy.
When you submit your registration, you will receive:
- an invitation to the live webinar on September 17, 2020 @ 1:30 pm EDT
- a native slide deck for the webinar
- a link to download a recording of the webinar
What you will learn from the MDSAP QMS Update Webinar:
- MDSAP requirements
- Overview of Country-Specific Requirements
- Certification Body Selection
Who should attend the MDSAP QMS Update Webinar?
This webinar, and MDSAP certification, is only for manufacturers. OEMs and contract manufacturers may benefit from ISO 13485 certification, but the MDSAP version of ISO 13485 is only applicable to manufacturers of medical devices. If your company is planning to market your product in Canada, MDSAP certification is required. If you are planning to market your product in the USA, Brazil, Australia, or Japan, MDSAP certification can simplify the process of complying with country-specific requirements. If you are the management representative for a company that plans to do business in one of those five countries, you can’t afford to miss this opportunity.
About Your Instructor
Mary is a biomedical engineer and consultant with Medical Device Academy. She graduated from Wichita State University and has experience in Q/A and BioMed. Mary has experience with 510k submissions for reprocessed single-use devices, sterile devices, electrical devices and standalone software. She also has experience with CE Marking and Canadian Licensing application. She served both as an engineer and the Head of Quality Assurance at Biomedical Devices of Kansas. As a guest speaker, Mary is going to explain how design controls and risk management should be integrated with the process of your 510k preparation.