Medical Device Design and Development and also Drug-device combination product plays a vital role in making the medical device which meets the quality expectations at par and may not lead to the customer complaints and failure in the market. The routes cause of most of the customer complaints, recalls, device failures are the poor medical device design and development activity. Any product failure is a major non-compliance & may result in adverse events affecting users.
During the design and development stage of the medical device design process, 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.
After analyzing a new medical device, the next step in its product development is the design. This is the most important stage in the development of a medical device for a flawed design may ahead of it being ineffective or risky.
At the design stage, a design control process system requirement. Being, design controls are simple and logical steps to ensure that what you develop is what you determine to develop and that the final product meets your customer’s needs and expectations.
For Best Medical Device Design and Development
The Efforts of Operon Strategist in helping us resolve our various regulatory queries have been outstanding. Their expertise & regulatory knowledge puts them on par with other globally recognized regulatory consultants.
We hired Operon consultant as a subject matter expert for overseeing sterilization activity by adhering to the protocol and for reviewing results and reports in line with global standards and our requirements for the commercial launch of a product in the global market. The team exceeded our expectations by providing quality outcome and played a vital role to launch the product in time.