Regulatory Submissions

Quality Assurance and Regulatory Compliance is a way of life.

We spent years developing a streamlined Quality Management System that we embrace as our primary tool to improve quality and efficiency. Every single employee, from the directors to the office assistants, is dedicated to the implementation and continued improvement of our FDA and ISO approved quality management system.

We have detailed and diligent processes and documentation for regulatory and safety training, risk analysis, design controls, prototyping and verification procedures and manufacturing operations. Our system is regularly audited by our own staff, BSI, the California and Federal FDA and our demanding clients.

“BC Tech's Quality Management System is continuously updated when better ideas are discovered. It is a totally transparent process that lets the system flex to meet the exact needs of the client's project. Our Employee Training Matrix is one of the best in the industry and ensures our entire staff embraces our quality procedures and is empowered to improve them.”

—Jim Talbot, Director of QA & RA

Comprehensive Quality Control

The appropriate controls are applied to every phase of your project, including

• Proper documentation and analysis of your Human Factors Studies and Risks & Hazards Analysis.
• Strict change control and document release protocols for design, development and manufacturing.
• Quality control systems for supply chain inspection, process validation, prototype development and manufacturing output testing and verification.

Your regulatory goals are the first priority.

We work intimately with your team to ensure your product achieves regulatory approval. Regulatory submittal strategies and special quality control concerns are considered from the very beginning of your project.

We can handle your regulatory submissions completely or help prepare documentation so you can do it yourself.