The transfers through design verification check points to validated medical device manufacturing are high risk elements of the development process. Ximedica’s manufacturing services team de-risks this critical phase by ensuring continuity is maintained resulting in a smooth passage.
The Manufacturing Services Team Produces Traceable, Compliant Products with Lowered risk and Controlled cost
From supply chain management through process development and production, the onsite Manufacturing Services team has the expertise to produce traceable, compliant products through robust, flexible solutions under a tried and tested Quality System. Early on in the process this team fully integrates with the project development team to assure processes and controls are in place based on intimate understanding of design intent.
FDA Registered to meet Class I, II and III Regulatory Controls
Ximedica is registered with the FDA as a contract manufacturer to support steady state, as well as non-commercial lower volume production like clinical trial builds and market test quantities. We produce both disposable and capital devices from component sourcing through final packaging and distribution.
Efficient Transfer of Products from Development to Production, Low or High Volume
Utilizing specialized systems we have in place Ximedica supports development through:
- Medical Device Feasibility Builds – Investigational device assemblies, or subassemblies, built with traceability and quality control appropriate for the intended use.
- Clinical Study Builds – Build out of adapted quantities of product design to use for clinical studies eliminating the burden of creating full production lines.
- Manufacturing Transfer / Production Builds – Production lines set up in our facility, our client’s facilities, or at an appropriate global contractor location ensuring process qualification, validations and satisfies the controls and cost of goods requirements.
- Global Component and Assembly Sourcing – Between our US and Asian offices we find the right priced components ensuring that the supplier is capable delivering these in a manner appropriate for the criticality of the medical device.
- Vendor Qualification and Relationship Management – Verification by our internal lead auditors of global suppliers’ quality management systems.
- Supply Chain Analysis – We work hard to reduce the number of suppliers in a chain, to encourage value added work at capable suppliers which leads to overall cost efficiencies, shorter lead times and reduced risks to delivery.