As an ISO 13485:2012-certified, FDA-registered contract manufacturer, Proven Process takes concepts to reality in our scalable, cGMP-compliant manufacturing facility. This facility features more than 20,000 square feet of manufacturing space, a Class 10,000 clean room, as well as model and prototype assembly labs. Oversight of supply chains is carefully managed for optimal costs, and the highest safeguards in documentation ensure lot control of raw materials. We have the talent and the resources to take your project from pilot to full-scale manufacturing with comprehensive and stringent project management oversight every step of the way.
cGMP cell based manufacturing efforts are managed with a flexible lean structure allowing for maximum efficiencies when building devices in small or larger volumes.
Proven Process's manufacturing facilities are compliant with Good Manufacturing Practices (cGMP) for medical devices. We believe that a system of checks and balances is a critical element in creating anything worth building.
For medical devices that are ultimately used to treat patients, quality is an imperative. To ensure your medical devices achieve FDA cGMP compliance, Proven Process has implemented a comprehensive quality management system covering design, manufacture, packaging, labeling, distribution, installation, and storage. Our quality assurance engineers and documentation experts work closely to ensure that all aspects of the manufacturing process are managed, adhered to and closely monitored.