New Product Introduction

Minimize Risk and Accelerate Speed to Market of New Medical Devices

The transfers through design verification check points to validated short run medical device manufacturing are well known to be high risk elements of the development process. It’s also where Ximedica’s integrated in-house capabilities offer the greatest value. From supply chain management through process development and production, Ximedica offers robust, flexible solutions and a tried and tested Quality System that lowers both the risk and cost of New Product Introduction.

Our diverse team of experts and disciplines create a seamless transfer of products from development to commercial launch. The manufacturing resources are part of the integrated development team and work in parallel, reducing time to market while assuring robust processes and controls based on intimate understanding of design intent. 

Our supply chain group leverages over 300 suppliers approved for medical device manufacture to assure the proper supplier is available for the particular application. This integrated team is focused on efficient delivery of products through verification, validation, and beyond.

Ximedica is registered with the FDA as a contract manufacturer to support steady state, as well as non-commercial production for efforts such as clinical trial builds and market test quantities. Ximedica produces both disposable and capital devices from component sourcing through final packaging and distribution.
                 

Services Include

Quality

• Design Verification & Validation
• Supplier Audits/Supplier Management
• Quality System Regulation compliant records
• Sophisticated process validation
• Metrology & Part qualification

Production Planning

• Quality Engineering
• Supply Chain Management
• Global Sourcing
• Order Fulfillment

Support

• Services and repair
• Return/complaint handling
• Sustaining Engineering

Facilities & Equipment

Ximedica has over 900 pieces of metrology and test equipment including Vision systems, Instrons, and environmental chambers. We have a sophisticated prototype shop and over 700 pieces of manufacturing equipment. Our facilities include class 8 clean rooms, clean manufacturing space, labs and controlled storage. Please ask for a full list.