Medical Device
Risk Management & Safety Cases

  • Optimization of Risk Management Processes for Safety and Compliance
  • Development of Safety Assurance Cases
  • Reviews of risk analyses for safety and compliance
  • Risk-based reviews of Software design and code
  • Implementation of the GessNetâ„¢ tool to support risk management
  • Integration of Risk Management into Agile Practices
  • Preparation or review of FDA premarket submission risk analysis and safety case documentation
  • Risk Management and Software Risk Management Training
  • IEC 62304, ISO 14971, 80002-1, 80001-1, 62366-1 Conformance
  • Efficient HealthIT Risk Management
  • Post-market safety risk management and adverse event investigations

We work cooperatively with your technical, quality assurance, and regulatory affairs staff, legal counsel, contractors, and vendors. We can help bridge the gap between your technical staff, regulatory, and quality groups, to articulate the validity of your approach to FDA and other regulators.

Our staff has many years of experience dealing with medical device and software risk and hazard management for FDA compliance, submissions, and safety purposes. Our experience ranges from low to high risk medical devices as well as risk-based approaches to validating Production and Quality Systems software and Part 11 compliance. We believe that properly performed risk management can improve the efficiency of design control and validation activities as well as ensuring safety and effectiveness. Several members of our senior staff that are recognized experts in risk management include: Sherman Eagles, Alan Kusinitz, Lucille Ferus, and Brian Pate.

Sherman Eagles was Convener of the IEC working group that developed the Programmable Electrical Medical Systems (PEMS) requirements in IEC 60601-1, Convener of IEC/ISO joint working group that developed IEC 62304 Medical device software life cycle processes and IEC 80002-1 Guidance on the application of ISO 14971 to software, Co-Convener of the IEC/ISO joint working group that developed IEC 80001-1 Application of risk management for IT-networks incorporating medical devices, Member of the working group for AAMI TIR38, Infusion devices – Assurance report case guidance.

Alan Kusinitz provided internal training at FDA and Health Canada and co-chaired with FDA development of AAMI TIR32 Medical Device Software Risk Management and participated in AAMI SW68 and IEC 62304 and 80002-1. He is co-developer and instructor for the AAMI/FDA Safety Assurance Case Course.

Lucille Ferus is now co-chair of the new AAMI Software Safety working group. Lucille Ferus was member of the AAMI/FDA working group that developed AAMI TIR32 Software Risk Management. She has provided training, developed tailored risk management processes and performed risk management to meet FDA and EU requirements for a wide range of Medical Devices and Production software.

Brian Pate was also a member of the AAMI/FDA working group that developed AAMI TIR32 Software Risk Management. He has provided public and private training, developed tailored risk management processes and performed risk management to meet FDA and EU requirements for a wide range of Medical Devices and Production software, including agile based processes. He has also provided internal training at FDA, is an active faculty member for public AAMI/FDA Software Validation and Agile Methods courses, and has also taught the AAMI/FDA Design Controls course. Brian is a former software engineer with extensive, in-depth knowledge of the strategy and design of software risk controls.

For more information contact us at info@softwarecpr.com or by phone at 781-721-2921