Premarket Submission, Validation & Cybersecurity for Software in Medical Devices

Event Information
Product Format
Prerecorded Event
Dr. Kosta Makrodimitris, PhD, CF-FDA, CP-EHR
60 Minutes
Product Description

Device Software Regulations: Here’s All You Need To Know to Enhance Patient and Consumer Safety

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:

  • Overview and timeline of biomedical software regulations
  • Premarket submissions for software contained in medical devices
  • Software validation for medical devices
  • Quality system regulations cGMP applicable to devices
  • Cybersecurity for medical devices that are networked
  • Information Security for certain kinds of devices
  • Off –The-Shelf(OTS) software for devices
  • Medical device data system rule as well as mobile medical applications
  • Future of software regulations and relevant standards in the biomedical field globally
  • Know about the FDA medical device approval process
  • General principles of software validation; final guidance for industry and FDA staff
  • Find out the validation of automated process equipment and quality system software
  • Overview of typical hazard analysis and mitigation
  • Understand cybersecurity vulnerability
  • Find out whether you need to report a cybersecurity patch
  • Identify the information security for certain types of devices

Who should attend?

  • Medical Device Professionals
  • Health Information Managers, Executives
  • Legal Counsel, Regulatory affairs
  • Software quality reviewers
  • Information Security Officers
  • Information Technology Managers
  • Data and Device Standards experts
  • Managers, Engineers of Software Quality, Validation
  • IT/IS Project Managers
  • Privacy Officers
  • Audit/Inspection coordinators
  • Device Compliance Officers
  • QA / QC managers, executives and personnel
  • IT / IS managers and personnel
  • Entrepreneurs (devices, mobile apps, software)
  • Medical Device Consultants

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About Our Speaker

Dr. Kosta Makrodimitris

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:

  • Advisor and participant (ONC/DHHS for Health IT, Standards & Interoperability Framework, Meaningful Use Stages/EHR, Federal Health Architecture, Health Information Exchanges-HIMSS, Health Level 7/ISO TC215 standards).
  • Executive director...   More Info
    More Events By The Speaker

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