Compliance services for ISO and
FDA regulations since 1994

Contact Us

Call Tim Stein at 1-408-768-7538

Client Testimonials

BPA took the time to understand our needs and business, supplied and implemented the tools required to obtain ISO 9001, and educated our staff to allow us to successfully maintain our certification. As the business needs changed, BPA was very responsive in working with our company to upgrade the system to successfully meet the medical device standards.

-Operations Director, Specialty Chemicals Company

The consultant did an excellent job in providing us clear direction and support as we adapted our processes to keep pace with the evolving demands of the medical device regulatory environment.

 -Vice President of New Product Development for a medical device company

BPA helped us establish our quality system and trained our employees on the requirements of ISO 13485. The consultant’s years of experience as a lead auditor for a Registrar provided exceptional insight. We knew how our processes would be assessed and had confidence as we faced our 13485 audit. In addition, her expertise enabled us to put a compliant quality system in place for a new plant.

-Manager of RA/QA for a medical device company

Quality System and Regulatory Services

BPA can help you achieve compliance with ISO 9001, ISO 13485, CMDCAS, QSRs, MDD, ISO 14971, and/or the cGMPs. Our consulting can include assistance with design control, risk management and software validation. We provide a wide range of services for many industries, with a focus on the medical device, pharmaceutical, combination products, biologics, CLIA, and the food industries. We have provided quality system consulting to over 100 clients, and have performed over 1500 audit days for Registrars and Notified Bodies.

Our approach is to build on your current practices to close gaps in a way that fits your company and is also compliant. We will determine how we can best work with you to ensure your success. We do not sell you a package of someone else's procedures. Our services frequently involve a gap analysis, support in becoming compliant, auditing, training, and support during registration.

For more information, see the following topics.

ISO 9001 services
  • Managing and / or supporting quality system implementation
  • Performing a gap analysis
  • Preparing an implementation plan
  • Developing processes, preparing procedures, implementation
  • Conducting internal audits
  • Addressing non conformances
  • Preparation for registration audits
  • Providing ISO 9001 training and internal auditor training
  • Transitioning from ISO 9001 to ISO 13485

We have helped over 100 companies achieve their quality system goals. We know what your auditor will be looking for. We have conducted over 1500 quality system audit days for Registrars. These audits cover a wide range of industries, for example PCBA, PCBs, sheet metal, metal fabrication, injection molding, chemicals, electronics, software, and biotech.

Medical device quality systems
  • Establishing compliance with the appropriate quality system regulations: QSRs (21CFR820), ISO 13485, CMDCAS, MDD, ISO 14971, IEC 62304, IEC 62366, IEC 60601-1, cGMPs (21CFR211)
  • Internal auditing against the QSRs, ISO 13485, CMDCAS, QSRs, MDD, ISO 14971, IEC 62304 (software), IEC 62366 (usability), and cGMPs as appropriate. Our head of these services has performed certification audits for two US registrars, notified bodies, Canada and Japan.
  • Gap analysis
  • Creation of procedures; implementation
  • Internal audits
  • Addressing non conformances
  • Preparation for registration audits
  • Product risk analyses
  • Product realization process risk management
  • Software validation
  • Design control processes, design history files, and technical files and dossiers
  • Software development processes per IEC 62304. See the Medical Device Software Regulatory Compliance page.

We have conducted over 1500 quality system audit days for Registrars and Notified Bodies.

Medical device regulatory submissions
  • Preparation of 510ks
  • Preparation of software artifacts (documentation) for 510k and PMA submissions
  • Preparation of submissions for cell phone Medical Device Apps
  • Preparation of design history files
  • Review of submissions for fit with regulators' requirements
  • Support in responding to inquiries from regulators
  • Preparation of technical files and dossiers needed for obtaining a CE Mark
  • Essential requirements analysis

We have special expertise in submissions for products that contain software. In addition, our German collaborators are recognized European experts in the development of software for medical devices, and associated regulations.

Combination drug and device products
  • Establishing one integrated quality system that meets the requirements of: cGMPs (21CFR211), QSRs (21CFR820), ISO 13485, and Part 11
  • Quality system training
  • Design control and technical files for the device component
  • Risk management for the product
  • Risk management for the product realization process
  • Preparation of a technical file for a CE Mark
  • Preparation of the medical device section of the FDA submission

We have experience in creating integrated quality systems for combination products

On-site training - internal auditor, standards, regulations, risk management, and software validation
  • Our training sessions on quality system standards can be general awareness training, or training tailored to different audiences such as management, product development, production, QA, and internal auditors
  • Our on-site internal auditor training includes the standard and how to audit to it, auditing skills, your internal audit process and forms, and practice audits with feedback from the trainers
  • We teach risk management of products, and risk management for the product realization process. These sessions include training on the ISO 14971 standard and performing hazard analyses and FMEAs. In addition, we can help you write a risk management procedure, prepare a risk management plan, facilitate risk management sessions and prepare the risk management report.
  • We train software engineers and regulatory affairs personnel on IEC 62304, Software Development Processes for Medical Devices, on design control, and on risk management

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

BPA resources
  • Visha, one of BPA's partners, has over 15 years of experience conducting audits for registrars and Notified Bodies. These audits have covered over 100 industry segments. Chances are that she has audited a company in your industry segment. She knows how the standards apply to your industry, what the registration auditor will look for, and the questions that he/she will ask.
  • We have set up complete systems for companies across a variety of industries, and have provided quality system services to over 100 clients including both small and large companies
  • The two BPA partners have a combined 40 years of experience in creating, improving, and auditing quality systems