Software Compliance and V&V for FDA & ISO

(including device, production, automated processes, mobile Apps, SaMD/SiMD, Cyber Security, AGILE updates, etc.)

(On-site or Virtual Private Group/Company Training)

Date: Your Choice

Location: On-site or Virtual

Who: Your entire company, department, project team, you select

Overview:
FDA & International regulatory scrutiny of software has become increasingly more sophisticated and in-depth. Devices and manufacturing processes automated with software gain considerable attention during submission reviews and manufacturing inspections. FDA requests for additional software information and documentation are frequent during 510(k) submission reviews and inspections. In fact, FDA's Software Guidance documents for Reviewer's Guidance, Validation, Cybersecurity and OTS (Off-the-shelf) Software significantly impact manufacturers! This course will help to understand how to comply to current regulations and how to prepare for future regulatory requirements & guidance both in the U.S. and internationally. You will receive the latest information regarding FDA regulations and guidance for software including device software, automated process software, mobile medical applications (Apps), cybersecurity, etc. Important international software standards and guidance will be discussed including IEC 62304, TIR 45 AGILE Practices. In addition to device software, discussion will include manufacturing process and test related software of any type of medical device, including disposables & as applicable to pharmaceuticals. This course is important in preparation for FDA & ISO Manufacturing and Design Control inspections; as well as, 510(k), IDE, PMA submissions or CE Mark approvals. Software SOP templates and Checklists applicable to auditing software will be presented. The course includes presentation of Software V&V process planning strategies using a risk-based approach consistent with ISO 14971 concepts for application of risk management to medical devices.

What you will learn:

• Content & impact of the latest Software Guidance Documents and Standards
• FDA & ISO policies, guidance & regulations.
• How to achieve FDA compliance-now and in the future.
• FDA enforcement actions and consequences due to non-compliance.
• Information applicable to auditing medical device software.
• Impact of Medical Device Standards including IEC 62304, TIR 45 / AGILE Practices.
• FDA expectations for Cybersecurity, SaMD/SiMD, & AI/ML.
• How to get and keep your software under control.
• FDA's position and guidance on Mobile Medical Applications (Apps)
• How to make compliance a by-product of your software development process.
• What to expect and what will be expected of you in an FDA inspection.
• Software requirements and guidance for 510(k), IDE & PMA submissions.
• How to implement a risk-based approach for development of Software V&V strategies.

Benefits of Attending:

• Preparation for the latest Software Guidance Documents and Standards
• 510(k), IDE, & PMA approval delays minimized due to software issues.
• Software compliance to FDA GMP/QSR/Design Control & ISO regulations.
• Provides means of determining compliance with FDA requirements.
• Reduced risk of delays, liability, and enforcement actions due to design or manufacturing compliance issues resulting from FDA inspections & ISO audits.
• Provides information to assess and manage the S/W development process.
• Provides information necessary to establish software process controls.
• Understand a risk-based approach as part of Software V&V planning.

Abbreviated Outline:

• A. Introduction
• B. Software Regulatory Overview
  • FDA Purpose/History/Focus/Software
  • Medical Device Definitions/Classifications
  • FDA Quality System Regulation & Software
  • ISO 13485 & Software
  • FDA & ISO Harmonization & Enforcement
• C. FDA Software Direction and Guidance
  • General Principles of Software Validation
  • Computer Software Assurance for Production & Quality System Software
  • Content of Premarket Submissions for Device Software Functions
  • Off-The-Shelf (OTS) Software Use in Medical Devices
  • FDA Cybersecurity Guidance
  • Mobile Apps Guidance & UDI
  • AI & Machine Learning
  • Additional FDA Software Guidance
• D. International Software Issues / Standards
  • Software Standards to Consider
  • Key Software Standards
  • IEC 62304
  • AAMI TIR 45 (Agile)
  • Additional Software Process & Product Related Standards
  • IEC 60601-1
• E. Software Development Life Cycle Processes
  • Traceability, Software Configuration Management & Change Control
• F. Software V&V Processes / Risk Based Strategies / Planning
  • ISO 14971 Concepts
• G. Software Development Life Cycle Example Template
• H. Operation & Maintenance of Software
• I. Summary & Conclusions

Instructor(s): To be determined based on schedule and your specific needs. All instructors are very experienced and experts in the field being taught. Biographies will be provided and a discussion with the instructor(s) will be arranged so that a proposal can be provided for training that meets your needs.

Duration: Standard course is approximately 8 hours. Customized courses can vary. On-site courses are typically taught in 1 day. Virtual courses can be taught over multiple days, e.g. 2 days for 4 hours/day, etc.

Request a training proposal for your company.

Be sure to reserve your date now!