Control the product. Control the records around it.
Medical-device manufacturing can involve precision components, engineered materials, controlled assembly, cleanliness, traceability, inspection, documented processes, supplier qualification, and tightly managed production changes.
The manufacturing system should support the specific technical and
Precision
Small features, mating interfaces, sealing surfaces, alignment, fit, and controlled geometry may require stable manufacturing and measurement.
Material Control
Material identity, grade, additives, certifications, supplier source, storage, substitutions, or lot information may require control.
Cleanliness
Product requirements may affect cleaning methods, handling, packaging, work areas, contamination control, and downstream processing.
Traceability
Parts, lots, materials, processes, inspection records, or production history may need to remain connected through defined identifiers.
Change Control
Material, supplier, tooling, process, inspection, software, equipment, or production-location changes may require formal review.
Documentation
Drawings, work instructions, inspection records, test results, specifications, revisions, and corrective actions can become part of the manufacturing record.
Used for precision housings, fixtures, structural components, instruments, prototypes, and metal or plastic device parts.
Supports repeatable polymer housings, disposable components, interfaces, covers, clips, handles, and other molded geometry.
Produces clips, brackets, contacts, shields, springs, retainers, and thin formed metal components at recurring quantities.
Mechanical assembly, fastening, bonding, joining, labeling, testing, packaging, and electromechanical integration may be combined.
Dimensional measurement, functional testing, visual checks, records, traceability, and controlled acceptance support finished-product verification.
The exact documentation required depends on the product and program, but controlled records can support traceability, acceptance, investigations, supplier management, and production continuity.
Process Capability
Confirm equipment, material experience, tolerances, cleanliness, secondary operations, testing, inspection, and production volume fit the work.
Quality Controls
Review document control, calibration, inspection, traceability, nonconformance, corrective action, training, and production records.
Change Management
Understand how the supplier reviews changes to materials, tooling, equipment, software, methods, outside processors, and locations.
Supply Continuity
Evaluate critical material sources, outside processing, specialized equipment, capacity, labor, long-lead components, and contingency planning.
Quality agreements can clarify inspection, records, change control, nonconformance, traceability, and acceptance responsibilities.
Quality Agreements →