FDA reviews information security, networking as well as wireless technologies during its premarket review of certain devices with vulnerabilities. Recently the agency offered guidance for mobile medical applications to ensure that they don’t pose risks for the patient. Device and healthcare industry need to take into account all these new and current biomedical software guidelines to provide services and products that ensure patient and consumer safety.
Software-related documentation in a premarket submission must be consistent with the projected use of the device and the level of concern and risk. Besides, there is the requirement to submit a device hazard analysis for all software devices and types.
Good news! This audio event conducted by our expert Dr. Kosta Makrodimitris will provide the current as well as expected policies for biomedical software for devices which are regulated by US FDA. It is critical to understand the categories of Medical Device Software for regulatory submissions (industry) or as user (doctor, hospital, patient).
With the help of reference documents at FDA and policies and guidances timeline, our expert will explain the current policies, update on upcoming regulations, explore issues and challenges and discuss how manufacturing, health IT and mobile industry will be affected. Examples and cases will be presented for various roles. Our expert will also explore relevant device software regulations, news and standards in US and globally.
Here are few topics covered in the session:
Who should attend?
Dr. Kosta Makrodimitris, PhD, CF-FDA, CP-EHR, is Biomedical/Health Informatics Advisor, Author & Strategist. He is certified on EHR/PHR, Clinical Trials, Biotech/Drug Development, and trained in US FDA/DHHS laws, regulations (medical devices, foods, drugs, personalized medicine, health IT). He is involved as: