As the leader in providing integrated quality management software systems to companies all around the world, MasterControl is making news and leading the way in solving business problems for all types of regulated manufacturers.
SALT LAKE CITY—Oct. 5, 2017—Alex Butler, medical device segment manager at MasterControl, and Linda Chatwin, senior consultant, Emergo, a UL Company, will be featured in a new webinar titled “Exploring the Medical Device Single Audit Program (MDSAP).” The webinar will take place from 1:00-2:30 pm ET on October 19, 2017. The webinar is hosted by The Advanced Medical Technology Association (AdvaMed). To register for the webinar, please visit https://www.advamed.org/events/exploring-mdsap.
The MDSAP represents a significant change for medical device companies seeking to prove regulatory compliance from international regulatory authorities. It allows medical device manufacturers to be audited just once for compliance with the standard and regulatory requirements of up to five different medical device markets: Australia, Brazil, Canada, Japan and the United States.
“MDSAP provides a time-saving solution for medical device companies seeking to audit against various regulatory requirements by taking an ‘all-in-one’ approach,” Butler said. “Those in the medical device industry must become educated and proactive as they prepare to open their doors to auditing organizations. This webinar will highlight the opportunities the MDSAP will bring to companies and explain how to take advantage of the new program.”
Many medical device companies plan to participate in the MDSAP in cooperation with the U.S. Food and Drug Administration (FDA). According to www.fda.gov, “FDA will continue to accept MDSAP audit reports as a substitute for routine Agency inspections.”
“For the last several years, the International Medical Device Regulators Forum (IMDRF) has commanded the work to create a framework that provides a standardized, internationally acceptable approach to auditing and monitoring medical device manufacturing,” Chatwin said. “There are significant benefits to having a single audit on a predictable timetable that is acceptable by multiple regulatory bodies, not least of which are potentially lower costs, improved quality systems and faster times to market.”
This webinar will explore the issues, challenges and benefits that surround the MDSAP. Butler and Chatwin will provide insight and conversation into how medical device companies can access the highest level of benefits via the program.
Agenda topics include:
1. Overview and benefits of the MDSAP
2. Who are the members of the MDSAP, and who will the program best serve?
3. Requirements for notified bodies qualifications
4. How to find more information on the MDSAP
5. How to prepare for the MDSAP
MasterControl Inc. produces enterprise software solutions that enable life science and other regulated companies to deliver life-improving products to more people sooner. MasterControl’s integrated solutions securely manage a company's critical information throughout the entire product lifecycle while reducing overall costs and increasing internal efficiencies. More than 1,000 companies worldwide ranging from five employees to tens of thousands use MasterControl’s suite of scalable cloud solutions for document management, quality management, electronic batch record management, supplier management, and clinical and regulatory information management. MasterControl solutions are known for being easy to implement, easy to validate and easy to use. For more information, visit www.mastercontrol.com.
More than 2,800 medical device and IVD companies in 60 countries worldwide look to Emergo for assistance with device registration, regulatory consulting, QMS compliance and in-country representation. The company has offices in 20+ countries and focuses on helping companies introduce new technology into new markets. More about Emergo can be viewed online at www.emergogroup.com