Development Process

Our comprehensive product development process which has evolved over the last decade is based upon creating and managing a collaborative effort between Sunrise developers and client representatives. It is built around an interactive team concept and stresses close working relationships with the client, user groups, industrial/mechanical design teams, testing/integration teams, and manufacturing management. Our project control procedures ensure that all regulatory and client goals are met, from concept up to the production phase.

Sunrise development complies with the recommended FDA and ISO design environment. Sunrise uses process controls and produces the documentation required as a specification developer under the guidelines of the FDA Quality System Regulations of CFR Title 21 (Part 820 sections indicated below) and ISO 9001:2000. To comply with ISO-13485:2003, Sunrise creates elements of the Design History File (DHF) and Device Master Record following Sunrise quality system standard operating procedures, or the client's process.

The Sunrise product development process is divided into five distinct phases:

• Client Requirements
• Specification and Architecture
• Product Design and Implementation
• Transition to Production
• Ongoing Support

Each phase entails thoughtful planning and analysis, thorough documentation, weekly reporting, and detailed quality reviews, all the while adhering to industry standards and client-defined validation and controls. Product development is conducted by our team of full-time engineers who have an intimate understanding of IEC 60601 and FDA Quality System Regulation.

Phase 0: Client Requirements

Prior to any detailed discussions a mutual nondisclosure agreement must be signed. More than just a legal formality, this is our way of declaring that Sunrise holds a client's intellectual property in the greatest respect. The activities in this phase are the beginning of the Design and Development Planning (820.30 (b)). The process of identifying business and technical goals, milestones and requirements for the project is begun and when funded appropriately Phase 0 will allow Sunrise to conduct an initial assessment of the project feasibility, hazard analysis, program cost and a schedule estimate.

Phase 1: Specification and Architecture

The Design and Development Planning continues in Phase 1 and Sunrise collaborates with client marketing and technical staff, as necessary, to further clarify and finalize the Design Inputs (820.30(c)). Client functional specifications are completed, regulatory requirements are determined, hazard analysis is completed and the Design History file is started. Our process demands that all Design Inputs are completed in Phase 1 and that the Design Output (820.30 (d)) documentation has been started. Hardware and Software Specifications must exist and our Design Review (820.30 (e)) checklist must be completed before transition to Phase 2. The resulting output from Phase 1 is a clear, conceptual product design, with well-defined architectural and technical approaches for implementation. The design is supported by a detailed project plan which identifies a schedule for all work to be performed.

Phase 2: Product Design and Implementation

The design process includes the completion of Design Output documents. The Hardware and Software design documents are completed, Design Verification (820.30 (f)) procedures are established and the development of all electronics, software, and mechanical design takes place. Prototype units are built and critical components / suppliers are identified and audited as required. The Design History files is maintained throughout the design process to ensure design changes are properly approved and documented ensuring efficacy of the final design. Sunrise has a formal check list and review sign off before transition to Phase 3. This includes a Design Verification Matrix that maps Product Specifications to System Architecture and Software Specifications to Hardware and Software Verification procedures ensuring Design Outputs meet the required Design Inputs.

Phase 3: Transition to Production

Once the design is complete Sunrise will work with the chosen manufacturer to build clinical units for Design Validation (820.30 (g)). Sunrise will work with the manufacturer providing any support required for production readiness. Full documentation is delivered and a fully installable release of software.

Phase 4: Ongoing Support

Once the product is complete and being successfully marketed, we are ready to provide various levels of support. Whether with primary or secondary support, or product enhancements, we are ready to address client needs. Typically the client and manufacturer have taken charge of the DHF and DMR but we are available for support as required. We will establish our own database for version control, enhancements, and fixes, and provide access to documentation and source files. Finally, a product support person is assigned to ensure the client receives immediate, complete attention.