Medical Device Design& Development
Medical Device Product Design & Development
Medical Device Design ControlUS FDA design controls under 21 CFR Part 820.Services meeting demands of clients looking for expanding their business ,reduce bottlenecks and manufacture new products.
Medical Device Product Development Process
Medical Device Verification and Validation
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.
After analyze 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 to it being ineffective or risky.
At The Design Stage , a Design Control Process system requirement .In 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.
The Design Control Process:
The Design Control Process Includes a set of interrelated method and Action that are documented and incorporated during the medical device design and development. Through design control acitivities ,A firm can:
- understand the competitor’s product. and Identify the customer requirement.
- Meet essential requirements necessary to achieve a high quality product ,from proceeding through to production.
- Establish a consistent process.
- Be reasonably sure that the end product works and meets customer needs.