Compliance services for ISO and
FDA regulations since 1994

Contact Us

Call Tim Stein at 1-408-768-7538

BPA offers on-site workshops on the topics listed below. Our hands-on training is delivered by experts with industry experience. The training emphasizes interaction, discovery and participative activities designed to develop useful on-the-job knowledge and skills.

Our workshops can be customized to meet your specific needs. BPA's consultants can train your employees or your trainers.

For information on each of the seminars, send us an email For information about consulting services in each area, see the appropriate web page.

Software Validation
  • "Validation of Applications Used in Production or Quality Systems"
  • "Execution of Validation Protocols"
Biomedical Quality Directives and Regulations
  • "The ISO 13485 Standard" - ISO 13485 training can be provided as awareness training, or tailored to different groups of employees, such as management, product development, production, QA, and internal auditors
  • "The FDA's Quality System Regulation"
  • "Quality Systems Requirements for Biomedical Industries"
  • "Internal Auditing"
  • "Design Control for Medical Devices"
  • "Compliance with ISO 14971 - Risk Management for Medical Devices"
  • "Risk Management of the Product Realization Process"
  • "Software Development Processes (IEC 62304)"
  • "Usability (IEC 62366)"
  • "Computer System Validation and Risk Management"
  • "Execution of Validation Protocols"
Software Regulatory Compliance
  • "Achieving Compliance with IEC 62304 - Software Development Processes for Medical Devices"
  • "Software Risk Management per ISO 14971"
  • "IEC 62366, Medical Device Usability Standard"
  • "Design Control Requirements - ISO 13485 and QSRs"
Risk Management
  • "Compliance with ISO 14971 - Risk Management for Medical Devices"
  • "Risk Management of the Product Realization Process"
  • "Software Risk Management per ISO 14971"
ISO 9001 Standard
  • "The ISO 9001 Standard" - ISO 9001 training can be provided as awareness training, or tailored to different groups of employees, such as management, product development, production, QA, and internal auditors
  • "Internal Auditing"
  • "Preparation for Registration Audits"
Part 11 Compliance
  • "The Part 11 Regulation"
  • "Part 11 Overview for Software Developers"