Xeridiem orchestrates the design, development and manufacturing of single-use, medical devices

Whether you are an established medical device company that is refreshing an existing product line or an innovator that needs help turning a concept into a product ready for commercialization, xeridiem offers a menu of services that can help you bring an innovative device to market.

We can help you at any or every step during the design, development and manufacturing process, including but not limited to design inputs, design history files, regulatory submissions, manufacturing and supply chain management.

Concept generation

Defines the marketing requirements of a device, including user and regulatory requirements for all domestic markets, the intended use, and business or legal requirements. Phase I produces device sketches or mock-ups.

Proof of concept

Demonstrates that critical design features of the selected design concepts perform as intended. This phase may include prototyping of critical design features and providing critical manufacturing processes. Create functional prototypes for use in focus groups, market research, and test marketing.

Product design and process development

Fully develops the design and manufacturing processes identified in the concept phases. Concludes with production of a detailed specification.

Design verification and validation

Verifies that the device design meets device specification, and validates that it meets the end user's intended use. Includes testing of functional prototypes in a lab setting or clinical setting.

Process installation and optimization

Establishes a manufacturing process and the equipment needed to consistently manufacture the device that meets our customer's required specifications.

Process validation and manufacturing transfer

Finalizes the validation of the manufacturing process through Process Qualification. Following this phase, the process is fully transferred to the manufacturing floor.