Pilot Manufacturing
Building your production prototype and finalizing your documentation.
If we're building complex laboratory equipment, the lead engineer of the project will oversee the initial build. If your product is a medical instrument, a small number of units will be manufactured under the supervision of our manufacturing engineers with support of development engineers as needed.
Your product's Manufacturing Process Instructions (MPI) and Quality Control Procedures (QCP) are refined and finalized during Pilot Production, resulting in:
- Complete and accurate instructions for manufacture
- Specifications for special tooling
- Clean room needs and procedures
- Sterilization and sterilization-verification protocols
- Packaging instructions.
- Lot Device History Record (DHR)
The MPI and QCP are combined with your design output to form your Device Master Record (DMR) and delivered alongside a complete Design History File (DHF). This documentation is produced under strict design controls and forms the foundation of your regulatory submittals.
Your product - finished, packaged and ready for use.
Your pilot-production products and DMR/DHF are done. Your medical device or biotech product is finally in the hands of health-care providers, treating real patients or analyzing real samples. Feedback is pouring in and you're finalizing plans for a market launch.
Depending on your clinical results, regulatory strategy and business objectives, you may choose to make minor changes to your product and DMR under control of BC Tech's QMS Change Procedures. No problem - in-house Pilot Manufacturing keeps flexibility easy and affordable.
