MEDICAL DEVICE MANUFACTURING / PARTNER SELECTION

Expert Medical Device Contract Manufacturer

ProTech Design provides medical device assembly, packaging, packaging validation, and sterilization management. Device companies can bring those needs to one manufacturing partner while defining which operations belong in the project and which remain with their own team. Our team has 45+ years of medical device packaging experience.

Which operations do you want to outsource?

Contract manufacturing lets a medical device company assign selected production work to a specialist. ProTech’s services include packaging design, assembly, packaging production, and post-production support.

Projects differ in what they outsource. We discuss the responsibilities your team will retain, the operations ProTech will perform, and how requirements and production information will pass between both teams.

Assembly and packaging

Assembly choices affect how a device is handled and packaged. ProTech supports hand assembly and automated production. Our packaging team considers device dimensions, materials, sterilization requirements, quality requirements, and cost when developing a packaging approach.

Custom and pre-validated packaging options are available. The production and packaging plans are considered together so the proposed scope reflects the finished device configuration.

Laboratory and sterilization support

ProTech’s in-house laboratory provides packaging testing and validation, including aging, seal strength, and package integrity testing. Outside testing agencies may be involved when a project requires additional work.

ProTech also manages sterilization through third-party partners. The project discussion identifies the proposed arrangement; managed sterilization does not mean every operation takes place at a ProTech facility.

Facilities and quality systems

ProTech’s medical device assembly work is performed in ISO 13485-certified facilities with Class 10,000/ISO 7-rated cleanrooms. These capabilities can be considered alongside the device-specific processes, documentation, and responsibilities required for your project.

Bring the device requirements, expected production needs, packaging questions, and validation considerations to the discussion. The project scope, cost, and schedule are confirmed after the work has been reviewed.

Manufacturing questions

Learn how we share manufacturing responsibilities with your team.

Do we have to outsource every operation?

No. The project can cover selected production responsibilities. Discuss the work your team wants ProTech to handle, together with device, packaging, and testing requirements.

Yes. ProTech’s offering includes sterilization management through third-party partners and may include additional testing through outside laboratories. The project scope identifies the services and who will perform them.

Tell us about your device

Tell us which operations you want to outsource and what your finished device needs to meet.