ProTech Design’s contract manufacturing work begins with your device requirements and the production work you want to outsource. The process can include project review, quoting, onboarding, assembly, packaging, and related validation. ProTech brings 45+ years of medical device packaging experience to manufacturing projects.
After an inquiry, our team reviews the project scope and discusses detailed requirements and timelines before preparing a quote. The conversation covers the device, the work you want to outsource, and information still in development.
Assembly, packaging, sterilization management, and validation may be included where they fit the project. The proposal spells out the selected services and responsibilities.
A manufacturing quote can address packaging, sterilization, and validation alongside production. We review how the proposed work fits the device configuration, packaging format, and testing recommendations.
ProTech offers custom and pre-validated packaging options, as well as hand assembly and automated production. The appropriate combination follows the device requirements rather than a fixed service bundle.
ProTech’s manufacturing services include packaging, assembly, and sterilization management. Steam sterilization can be performed on-site; EtO and gamma sterilization are managed through third-party partners.
Our in-house laboratory handles packaging testing, while additional tests may involve outside laboratories. The project scope confirms the sterilization arrangement, testing responsibilities, and validation work.
Once the proposal is accepted, onboarding establishes the project and its production requirements. ProTech’s ISO 13485-certified facilities and manufacturing engineers support the agreed assembly and packaging work.
Before production commitments are made, the project team confirms responsibilities, required records, and open technical questions. Timing and cost reflect the agreed scope.
Find out what happens before production begins.
Our team reviews the project needs and scope, then discusses detailed requirements and timelines. The quote reflects the proposed production work and relevant packaging, sterilization, and validation details.
ProTech provides sterilization management. Steam sterilization may be performed on-site, while EtO and gamma sterilization are managed through third-party partners. The method and arrangement depend on the device and project scope.
Send us your device requirements and the assembly, packaging or testing work you need quoted.
