Product Development Solutions Comprehensive Solutions for Assay & Kit Development

Establish strategy and plan to define responsibilities for design and development activities.

Ensure Design Inputs meet customer requirements and address the intended use. Design Inputs need to be documented, reviewed, and approved.

Ensure Design Outputs are clearly defined and conform to
Design Inputs. Design Outputs need to be documented, reviewed, and approved.

Formal, documented Design Reviews need to be conducted at
key stages by cross-functional teams and recorded in the Design History File (DHF).

Studies and procedures to verify device design and to confirm that Design Output meets Design Input requirements. Study designs and results of design verification are formally documented, reviewed and approved.

Ensure that device design conforms to defined user needs and intended use through testing under real or simulated conditions. Includes risk analysis and software validation (if applicable).

Ensure accurate translation of device design into production specifications. Require formally documented, reviewed and approved procedures.

Establish procedures for identification, documentation, validation and/or verification, review, and approval of design changes before implementation.

Establish and maintain a DHF that contains records necessary to demonstrate that the design was developed in accordance with the
approved design plan.