Compliance services for ISO and
FDA regulations since 1994

Contact Us

Call Tim Stein at 1-408-768-7538

International and Local Collaborations

BPA's collaborations include:

Dr. Christian Johner, Healthcare IT Institute, Konstanz, Germany

Dr. Johner is one of Germany's leading experts on software development for medical devices and medical device regulations. Dr. Johner founded and runs the Healthcare IT Institute in Konstanz, Germany. The institute teaches employees of medical device companies and notified bodies on both methodologies for software development and software regulatory compliance. Dr. Johner is a recognized European expert in software development processes (IEC 62304), risk management (ISO 14971), medical device usability (IEC 62366), and medical device safety (IEC 60601). In addition, Dr. Johner is a professor for software architecture, software engineering and medical informatics.

Dr Johner brings to BPA and our clients a wealth of knowledge of the European regulations and his 20 years of experience in consulting. The consulting services he provides as part of the BPA team include addressing questions on the application of standards to a particular device or development effort, responding to notified bodies, training on the standards, and writing and reviewing technical files. His software development services include software architecture and software verification and validation.

The Product Realization Group

The Product Realization Group (PRG) (www.productrealizationgroup.com) has developed a "one-stop-shop" for outsourced services that helps companies bring new products to market. Engagements are tailored to the business. The PRG partners work together to deliver services that range from initial concept through global logistics and repair. BPA provides quality system consulting and regulatory compliance services as a member of the Product Realization Group. This includes: establishing quality systems, medical device software compliance, 510(k) submissions for devices with software, and medical device software testing.

Voler Systems

Voler Systems (http://www.volersystems.com) provides the highest quality consulting engineering services for new product design. Voler reduces the risk in new product design with a proven process and ensuring a smooth transfer to manufacturing. Since 1979, clients have turned to Voler for reliable new products involving sensors and measurement electronics. The Voler multidisciplinary team delivers quality products, on time, and on budget with low risk. Voler has developed medical devices, automatic test equipment, heart valve testers, RFID devices, instrumentation design, data acquisition systems, and other specialized sensor-based electronics and prototype circuits. BPA has worked with Voler in creating software development deliverables that are compliant with the requirements of the FDA and IEC 62304.

Affiliated consultants

In addition, BPA works with many affiliated consultants that bring additional resources of time and expertise to a project on an as-needed basis. Areas of expertise include: regulatory submissions, software development, software testing, electrical engineering, mechanical engineering, and transitioning from product development to manufacturing.