-Operations Director, Specialty Chemicals CompanyBPA 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.
-Vice President of New Product Development for a medical device companyThe 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.
-Manager of RA/QA for a medical device companyBPA 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.
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.
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.
We have conducted over 1500 quality system audit days for Registrars and Notified Bodies.
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.
We have experience in creating integrated quality systems for combination products
For a complete list of BPA training offerings, see Training Services