Once a conceptual design has been finalized, Micro Engineering Solutions works towards the initiation of pilot production, testing out the chosen manufacturing process and assembly strategy.
Our goal in the pilot production phase is to successfully transfer the chosen design into manufacturing specifications for mass production, and also to validate and document the manufacturing and assembly processes for the product being developed.
Once pilot products have been fabricated under manufacturing control, Micro Engineering Solutions carries out tests to validate and document that the products conform with the original design intent and are fit for purpose. Device history and master records are produced, the validation test results are evaluated by our product development team, and quality control and production fixtures and assembly equipment are designed and built where necessary.
Parts produced in the pilot production stage are used in clinical trials, prove a device’s safety and effectiveness, and to win clearance from regulators.
Micro Engineering Solutions conduct a final Manufacturing Readiness Review (MRR) after pilot production units are built and design validation is complete, to verify that the product is ready for full-scale manufacturing. This review verifies that all appropriate design, validation, and manufacturing preparations are complete and the program is adequately prepared to move to the production phase.