FALLS CHURCH, Va., Jan. 16, 2019 /PRNewswire-PRWeb/ -- Regulating Software Used by Life Science Manufacturers Is it a Medical Device or Not? **An FDAnews Webinar** Wednesday, Jan. 30, 2019, 1:30 p.m. - 3:00 p.m. EST
http://www.fdanews.com/ regulatingsoftware
Struggling to figure out what software as a medical device (SaMD) is?
Life science companies using software in clinical trials, software developers, and producer of artificial intelligence products need to know what software is a medical device and what's not.
Off-the-shelf applications, used in a manner the software manufacturer didn't intend, must be compliant with device regulations.
Many life sciences manufacturers simply don't realize products will be considered a medical device and don't know what regulations apply. James Rogers, founder and head of Compass Life Science Solutions, has more than 20 years experience dealing with compliance requirements. Over the course of 90-minutes he'll help attendees understand:
Meet The Presenter: James Rogers, founder and head of Compass Life Science Solutions, has more than 20 years experience dealing with the compliance requirements of various standards and regulations. He has helped companies achieve compliance with GAMP, 21 CFR Parts 11, 58, 210, 211, and 820, ISO 9000, 13485 and 14971, IEC 62304, the European MDD and MDR directives, and Annex 11. His industry experience includes the manufacturing of medical devices, and implementing regulatory compliant software and datacenter services. Most recently, Rogers has been working with companies to develop compliance strategies and methodologies to support the utilization of cloud based solutions as medical devices.
Who Will Benefit:
Tuition: $287 per site
Easy Ways to Register: Online: http://www.fdanews.com/ regulatingsoftware By phone: 888-838-5578 or 703-538-7600
About FDAnews: FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.
SOURCE FDAnews
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Struggling to figure out what software as a medical device (SaMD) is?
Life science companies using software in clinical trials, software developers, and producer of artificial intelligence products need to know what software is a medical device and what's not.
Advertisement
Off-the-shelf applications, used in a manner the software manufacturer didn't intend, must be compliant with device regulations.
Many life sciences manufacturers simply don't realize products will be considered a medical device and don't know what regulations apply. James Rogers, founder and head of Compass Life Science Solutions, has more than 20 years experience dealing with compliance requirements. Over the course of 90-minutes he'll help attendees understand:
- The process that should be used to classify an SaMD based on U.S. and international guidance
- How a company's use of a software product impacts the classification of SaMD
- When a purchased software product becomes an SaMD
- Remediation approaches to resolve SaMD compliance issues
- Best practices on development and validation strategies for SaMD
Meet The Presenter: James Rogers, founder and head of Compass Life Science Solutions, has more than 20 years experience dealing with the compliance requirements of various standards and regulations. He has helped companies achieve compliance with GAMP, 21 CFR Parts 11, 58, 210, 211, and 820, ISO 9000, 13485 and 14971, IEC 62304, the European MDD and MDR directives, and Annex 11. His industry experience includes the manufacturing of medical devices, and implementing regulatory compliant software and datacenter services. Most recently, Rogers has been working with companies to develop compliance strategies and methodologies to support the utilization of cloud based solutions as medical devices.
Who Will Benefit:
- Owners of SaMD companies
- Quality individuals responsible to the use of software in clinical trials
- Quality individuals responsible for the validation of device software.
Tuition: $287 per site
Easy Ways to Register: Online: http://www.fdanews.com/ regulatingsoftware By phone: 888-838-5578 or 703-538-7600
About FDAnews: FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.
SOURCE FDAnews
