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Device development

Concept

Concept development, including design-FMEA (Failure Mode and Effect Analysis), is performed in collaboration with the customer's engineering team.
 
Evaluation of the feasibility of each manufacturing step
Manufacturing capability study (Cm) for internal and supplier production means: Predicting likelihood for parts/dimensions not complying with the specification
Production process capability study (Cp) for all parts: Proportion of parts manufactured within the specifications. For serial manufacturing MPS works with Cpk >1.33 meaning that the manufacturing process is 100% under control.
Classifications of Characteristics C of C: Productions-FMEA giving a measurement system for all critical dimensions.
Partnerships with sub-contractors and installation of identical QAS: All suppliers in the program are labelled 'Qualified Manufacturer'.
Vertical integration of critical manufacturing steps.
Qualification Building
Assembly tools and processes for serial manufacturing are defined and put in place.
Assembly environment is qualified.
Packaging is tested and qualified
At end of the Qualification Building Milestone all assembly processes and environments are qualified.
Serial production
production ramp up
validation run of the overall production
Ready to go into serial production while respecting the most demanding quality assurance requirements