|Minimum Order Quantity||1 Unit|
|Category||medical device product design and development|
The medical Device manufacturing companies should have to maintain document procedure for Design and Development
Operon Strategist, guides to plan and control the design and development of the product, as appropriate, design and development planning documents shall be maintained and updated as the design and development progress.
During Design and development, operon shall guide in following ways
A. Design and development planning.
Guide to the design and development stages.
The review(s) needed at each design and development stage.
The verification, validation, and design transfer activities that are appropriate at each design and development stage.
The responsibilities and authorities for design and development
The method to ensure traceability of design and development outputs to D & D inputs.
The resources needed, including necessary competence of personnel.
B. Design and Development inputs and outputs, Review, verification, validation, transfer, changes
Medical Device Design and Development failure in any product is a major non-compliance & may result in adverse events affecting users. During design and development stage of the Medical device design, we assist various Medical device manufacturing industries to ensure that appropriate steps are taken to meet regulatory compliances of the Medical device design and development.