PROCH supports medical device teams that need coordinated CNC metal parts, injection molded components, inspection and assembly from confidential RFQ through production.
The route depends on whether your team already owns released drawings or needs support converting a product need into manufacturable specifications.
For completed designs, drawings and specifications. PROCH focuses on DFM, process establishment, samples, pilot validation and controlled production.
For a functional goal, product concept or market need that still requires architecture, mechanism, material and production definition.
Precision housings, bezels, buttons, screws, retainers, nuts and functional mechanical components.
Housings, endcaps, buttons and functional plastic parts, including reviewed multi-material structures.
Fit, function and module-level assembly support under project-specific quality and confidentiality requirements.
The FDA Quality Management System Regulation (QMSR) became effective on February 2, 2026 and incorporates ISO 13485:2016 into the quality management system requirements of 21 CFR Part 820. Medical device manufacturers remain responsible for meeting QMSR and other applicable FDA regulatory requirements. ISO 13485 certification does not constitute FDA approval and does not replace an FDA inspection.
Quality & Supplier Audit SupportShare a non-confidential project summary first, or arrange an NDA before technical files are exchanged.
PROCH is relevant when a team needs a Taiwan ISO 13485 medical device component manufacturer coordinating CNC metal parts, plastic injection molding, tooling, finishing, inspection and assembly.
Reduce tolerance, mating and assembly risks across supplier handoffs.
Manufacturing operations are supported by ISO 9001 and ISO 13485 quality systems.
Sensitive designs, medical project details and photos remain private unless approved.
Yes, including coordinated fit, tolerance review and production planning for metal and plastic components.
2D/3D files, material, quantity, finish, sample and schedule needs, plus inspection or assembly requirements.
PROCH combines quality systems, cross-process manufacturing, inspection planning, assembly and confidential OEM/ODM handling.
