Software as a Medical Device (SAMD) – Practices for Ensuring FDA Compliance

Live Webinar

  • 90 minutes

Medical device companies must be vigilant in understanding the factors that impact their ability to operate with oversight from FDA as it relates to computer system validation and the life cycle approach to maintaining software used with medical devices, as well as software that serves as a medical device (SAMD).

In all cases, companies should do the right thing and have robust computer system validation programs that are well executed and documented. However, there are some extremes in oversight that occasionally crop up and may cause expectations to go above and beyond what is considered reasonable. In such cases, companies must determine how much risk to take in terms of the strength of their programs, and how well they are able to negotiate with their FDA auditors.

Join this session by expert speaker Carolyn Troiano, where she will focus on the importance of managing FDA oversight of computer system validation in the medical device industry by anticipating and preparing for trends. The type and extent of oversight varies with changes to the economic, political, and business environment. FDA funding, the length of government reach into the private sector, and the ability of companies to lobby the government for less regulation all play a role in terms of the dynamics at play between industry and the FDA.

Session Highlights:

  • This webinar will focus on medical devices, software as a medical device (SaaMD) and what is required for compliance with FDA.

  • Medical devices can use very complex software applications, and any failure to function properly could lead to potential injury or death of a consumer or patient.

  • There is a need to improve overall standards for medical device software to account for this high risk potential.

  • The majority of software recalls in the 1990s were due to software defects that were a result of software being upgraded.

  • There is a need to restructure medical device software development processes, and adopting IEC 62304 provides a standard for design that is accepted in the United States (US) and European Union (EU).

  • IEC 62304 is a risk-based, lifecycle approach that defines the activities and tasks required to ensure software for medical devices will be safe and reliable, and applying this standard will reduce your overall rate of software failure and improve your bottom line.

Why You Should Attend:

This session will provide insight into the IEC 62304 standard as it is applied to medical device software.

  • You will learn how to apply this standard to your own work processes.

  • You will learn about industry best practices for delivery of reliable and safe software for medical devices.

Who Should Attend:

  • Information Technology Managers

  • Information Technology Developers

  • Information Technology Analysts

  • Information Technology Testers

  • QC/QA Managers

  • QC/QA Analysts

  • Compliance Managers

  • Laboratory Managers

  • Automation Analysts

  • Manufacturing Managers

  • Manufacturing Supervisors

  • Supply Chain Specialists

  • Computer System Validation Specialists

  • GMP Training Specialists

  • Business Stakeholders responsible for medical device design, development, manufacturing, testing, and distribution

  • Consultants working in the medical device industry

  • Auditors engaged in the internal inspection of medical devices

*You may ask your Question directly to our expert during the Q&A session.

** You can buy On-Demand and view it as per your convenience.

Carolyn  Troiano

Carolyn Troiano

Carolyn Troiano has more than 35 years of experience in computer system validation in the pharmaceutical, medical device, tobacco and other FDA-regulated industries. She is currently an independent consultant, advising companies on FDA compliance, computer system validation and large-scale IT system implementation projects. Carolyn participated in the Industry/FDA partnership that developed 21 CFR Part 11, the FDA’s guidance on electronic records and electronic signatures (ER/ES).

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