Medical Device Design & Development
Ranfac designs and develops products for our own product line as well as multiple customers around the world. Our process for releasing product consists of multiple phases that are designed to ensure a successful launch of all newly designed products.
Phase 1: Concept
This phase includes defining the project to ensure all product requirements are understood. Extensive customer interaction between the customer application engineer and the design engineer at Ranfac occurs during this phase to ensure requirements are understood.
Phase 2: Prototype
During this phase, Ranfac builds product that is owned by the engineer assigned to the project. Every step of the process is controlled by the engineer to ensure all documentation and specifications are created and followed accordingly. IQ/OQ/PQ is initiated during this phase. Quality Assurance along with your dedicated project manager will perform these validations.
Phase 3: Release to Pilot (RTP)
The pilot phase is designed to ensure everything that was learned during the prototype phase has carried over into the next run of product. This phase ensures all manufacturing personnel can repeatedly produce product that meets all customer and/or Ranfac requirements. Tools used during this phase include capability studies, designs of experiments and validations.
Phase 4: Release to Manufacturing (RTM)
This is the phase in which engineering hands the product over to manufacturing, and operations has control going forward. This phase cannot be entered until all requirements of the previous 3 phases are met.
Throughout the development process, Ranfac revises the PFMEA to ensure all risks are mitigated accordingly. Control Plans are updated to capture all documentation required to build the new device. This 4 phased approach to launching products has proven to be very successful for Ranfac Corp and our partners.