Compliance services for ISO and
FDA regulations since 1994
Contact Us
Call Tim Stein at 1-408-768-7538
Quality System and Regulatory Services
Medical Device Software Regulatory Compliance and Documentation
Software Validation and Risk Management
Training Programs
Quality System and Regulatory Services
BPA provides a full range of services for establishing quality systems, auditing, addressing non conformances and evolving your system to meet business changes. We can help you achieve compliance with ISO 9001, ISO 13485, CMDCAS, QSRs, MDD, ISO 14971, and/or the cGMPs. In helping you build a compliant system, our objective is to meet your business needs while seeing the system through the eyes of a Registrar.
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Medical Device Software Regulatory Compliance and Documentation
We bridge the worlds of software development and regulatory compliance. We are adept at translating quality system regulations for engineers. We help establish software engineering processes that comply with the QSRs, ISO 13485, the MDD, IEC 62304, ISO 14971, IEC 60601, and IEC 62366. In addition, we write or review documentation on software for FDA 510k submissions and CE technical files.
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Software Validation and Risk Management
BPA works with regulated companies to validate the software they use in production and their quality system. We also work with the developers of such applicants to validate the applications they place in the cloud. Our services range from performing validations to training and supporting your validation team.
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Training Programs
Our training emphasizes interaction, discovery and participative activities designed to develop understanding and useful on-the-job knowledge and skills. Our hands-on training is delivered by experts with industry experience. Our workshops can be customized to meet your specific needs.
Read More- Client Testimonials
“In 15 years as an auditor, a BPA client was the only company I audited to have no major or minor non conformance.”
-Lead auditor for a Registrar
“The BPA consultant proved to be instrumental in bridging the gap between R&D/engineering and regulatory. The consultant has a wealth of experience in all aspects of regulatory compliance, his in-depth knowledge of 62304 and how this standard translates into the real world of medical device development is outstanding. The consultant was dedicated, personable, professional and a delight to work with.”
-Vice President RA/QA for a medical device company