Design Process

Lighthouse Imaging's Design Process

Design Process Overview
• Closely follow FDA CFR820 & ISO13485 Design Control Process
• Design Control Process under QA control – Q2P-7.3
• Close control of when manufacturing fully takes over the process
• Contract base projects, where LIC stops at Design Verification
• LIC supports clients through their Design Validation Process
• Manufacturing heavily involved with Design Transfer
• All projects designed for manufacturability
Project Scaling Plan
• Identifies the deliverables for each phase of the program
• Allows client to determine where to start design transfer activities dependent on client’s needs
• E.G., start doc transfer, create ERP BOMs, complete DMR, MPIs, LHTs, Work Instructions, Close Quality Plan, etc.
• Place activities in the Design Validation Process to expedite market launch
• Changes during the project are captured and published
• Used as a guide during the Design Transfer process
• Client, Engineering and Manufacturing, including Quality involved
Design Transfer
• Design Transfer is the systematic method to ensure a device design is properly transferred into production specifications
• Transfer of the design from engineering into manufacturing may require the following:
• Review & approval of device drawings, specifications & protocols
• Validate manufacturing specifications, methods, procedures through pilot or pre-production runs
• When required, process validation or process capability studies – IQ, OQ, PQ
• Completion of the Master Validation Plan (MVP)

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Brochures, White Papers & Video

Brochures, White Papers & Video

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Lighthouse Imaging Patents

Types of Endosopes

Different Types of Endosopes Reference

News & Events

News & Events