About PrepcoPrepco has 30 years of contract medical component manufacturing specializing in minimally invasive, disposable surgical components.
We focus carefully on each aspect of manufacturing. Our exceptional product quality and success at solving complex manufacturing issues lead the industry.
What makes us stand out?
We focus carefully on each aspect of manufacturing, from concept discussions to final product testing. Our exceptional product quality and success at solving complex issues lead the industry.
Our Work Environment
We follow controlled work environment methods carefully, utilizing double door entry, entryway tacky mat floor coverings, protective garments and positive pressure HEPA filtered work areas. The work table surfaces are wiped daily with 70% isopropyl alcohol.
We conduct laser particulate air sampling and work surface viable particulate count.
Inspections of components and raw materials are conducted within HEPA filtered areas.
Our Certificates and Authorizations
Prepco strictly adheres to FDA Quality System Regulations. Products are manufactured according to CFR 820 regulations (Code
of Federal Regulations, 21 CFR Ch. 1, part 820, Good Manufacturing Practice for Medical Devices, Subpart A-J.
Prepco also meets ISO EN13485:2012 and ISO 13485:2003 requirements and specifications.
Our Documentation and Quality Assurance Testing
The presence and indentification of each component can be traced by its controlled lot number during the manufacturing process and in any and all shipments of completed devices. Prepco maintains Device Master and Device History Records, available for inspection at any time.
Our quality assurance is serious business. All components and material inspections are conducted within HEPA-filtered laminar flow units meeting all federal standards which maintain clean room quality from manufacturing through testing.
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