Compliance services for ISO and
FDA regulations since 1994

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Call Tim Stein at 1-408-768-7538

Client Testimonials

The BPA consultant’s deep understanding of the medical software regulations has been key to our ability to bring our development process into compliance. He helped us understand what the regulations called for and where our gaps were. His ability to listen once to what we needed and come back a few days later with process proposals that matched our needs and development style while fulfilling regulatory requirements, was precious. I don't think we would have gotten our CE Mark that easily without his invaluable help.

-Director of Software Development for a medical device company

"The Business Performance Associates (BPA) consultants were instrumental in helping our company define and establish medical device software life cycle and quality assurance processes consistent with IEC 62304. Our organization had no prior experience in medical device software development, and BPA was able to guide us through developing necessary procedures while helping the organization gain the understanding of how each of these procedures would improve our product.

-Director of Software Engineering for a medical device company

Medical Device Software Regulatory Compliance and Documentation

BPA's consultants are experts at the interfaces of software development, quality assurance and regulatory affairs. We translate the regulatory and compliance requirements for software developers in the creation of both compliant software procedures and the software artifacts (documentation) needed for submissions.

One of our areas of specialization is compliance with IEC 62304 for software development processes. In a gap analysis, we evaluate your processes and documentation against the 62304 requirements. We team with you to improve compliance by writing procedures that build on your software development practices, and we work with you to close any content gaps in your deliverables.

For more information, see the following topics.

Services for achieving compliant software development processes and procedures
  • Gap analysis
  • Training on IEC 62304, design control requirements (ISO 13485 and the QSRs), software risk management (ISO 14971) and usability (ISO 62366)
  • Collaboration with developers to build on their processes to achieve compliance
  • Writing procedures
  • Editing associated procedures for consistency, such as design control and risk management

We translate regulations and support both software developers and device companies

Preparing software artifacts (documentation) for a CE Mark and / or a FDA submission
  • Writing artifacts
  • Reviewing artifacts against requirements for submissions, EU requirements and FDA guidance
  • Providing templates for plans, requirements, design documentation, risk analysis, and testing
  • Leading software risk management activities in compliance with ISO 14971
  • Facilitating usability analyses in compliance with IEC 62366
  • Integrating the requirements for software artifacts into the software development life cycle

Regulatory Affairs should not have to rewrite software documentation for submissions; it should be generated from the software development life cycle

Managing outsourced software development
  • Training the medical device design team on the software regulations and what the device manufacturer and outsource developers need to do
  • Qualifying software developers
  • Preparing a statement of work and/or quality agreement between the medical device company and the outsource developer
  • Providing templates for software artifacts (software development plan, requirements, design, etc.)
  • Reviewing or writing artifacts

We work with both medical device companies and software development companies to ensure that software development processes and artifacts meet regulatory requirements

Cell phone medical device apps
  • Determining whether or not the app is a medical device and what regulations apply
  • Assisting you in meeting the software engineering regulatory requirements
  • Helping prepare the software artifacts needed for regulatory approval
  • Preparing 510k submissions for the FDA
  • Preparing the documentation needed for a CE Mark

We will help you meet regulatory requirements for software engineering and prepare submissions for regulatory approval

BPA medical device software verification services

BPA provides services related to the testing (verification) of software that is in medical devices, or that is a medical device itself. The following are examples of such services:

  • Performing a device hazard analysis and / or software risk analysis and identifying the implications for software design, verification and validation.
  • Establishing quality assurance processes for device software.
  • Performing medical device software testing (verification), including a test plan, preparing and executing software tests and writing reports, and preparing traceability matrices.
  • Preparing documentation on software unit, integration and system tests and test results for submission to the FDA and/or as part of a technical file.
Obtaining regulatory approval
  • Preparing a regulatory strategy and plan
  • Preparing or editing software and hardware documentation that is part of the technical file for a CE Mark or FDA submission
  • Reviewing your submission to anticipate notified body and FDA reviewers' questions
  • Assisting in crafting responses to queries from regulators

We help companies prepare FDA submissions and EU technical files, with a special expertise in medical devices with software

On-Site Training
  • "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"

For a complete list of BPA training offerings, see Training Services

BPA Resources
  • Our US based consultants are experts in software development processes, software artifacts, quality system requirements and regulatory submissions
  • The BPA Founder has given numerous webinars and presentations on software regulatory compliance topics, including: IEC 62304 compliance; managing outsourced software development to be compliant with IEC 62304; and medical device smart phone apps
  • Our US affiliates include electrical, mechanical and software engineers
  • Our European collaborators are experts in software development and the EU regulations for software development and medical devices