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Corporate Recorded: Access recorded version, Any number of participants unlimited viewing for 6 months ( Access information will be emailed 24 hours after the completion of live webinar)
Global Medical Device Regulations continue to evolve, as devices become more diverse and sophisticated.
Understanding the regulations and requirements in your targeted markets will expedite the speed-to-market of innovative products and assist patients needing access to life-saving products and technologies.
Government Regulatory Authorities, needing to become more efficient with their time, are looking for ways to better use their internal resources without compromising safety in products, which become marketable.
One such example is the Medical Device Single Audit Program [MDSAP], where Authorized Organizations would be allowed to carry out a single GMP audit on medical device manufacturing facilities and have it stand to support registrations across the current participating member countries: U.S. Canada, Brazil, Australia, and Japan. Health Canada has now made the MDSAP process mandatory for all licensed products in Canada.
Why you should Attend:
This 4-hours seminar is focused on understanding the Medical Device Single Audit Program, the scope of the program, how to apply, the Authorized Organizations, the rating system developed, and what you can expect when signing onto the program.
The seminar will discuss how such audits are organized, what to expect during an MDSAP audit, and how this differs from a typical certified body audit, along with document movement and timeline expectations in receiving the facility’s certificate.
Highlights of the key Regulatory Requirements for Medical Devices will also be covered for the participating MDSAP Countries of: U.S., Canada, Brazil, Australia and Japan.
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