Concurrent Supply Chain and Process Development are key to the successful launch of Medical Devices
We engaged Rohtek to help us with Process and Specification Audits to develop a robust process and reduce risk of field defects.
Rohtek used a Process FMEA approach working with our Design Engineers, Supplier Quality Team, and Suppliers to map specification requirements to the Supplier process control plan and Test Process to ensure that all specifications were adequately controlled.
Rohtek also helped us resolve gaps in our specications that made them more complete. Resolved gaps in Supplier process control, and helped to mistake proof the Supplier process.
I would highly recommend Rohtek as a Supply Chain Quality Assurance Partner