Chilka Vinod Kumar*, K. Sudheer, Brahmaiah Bonthagarala, M. V. Nagabhushanam, D. Nagarjuna Reddy, G.Ramakrishna.
Abstract:
Every marketable medical device needs deep level engagement, considering the complexities involved due to the requirements, usage patterns, user experience, regulations, associated iterative process, technologies, material, and many more. To stay in line with competition or decrease time-to-market, you may need help from an experienced medical device engineering consultants or service providers. Medical devices are also becoming smaller and more complex in design, sometimes using advanced, engineered plastics. This makes the process of validation and verification (V&V) even more important not only to comply with regulations, but also design the highest quality part and production process. The result is better repeatability, fewer mistakes, less rework and redesign, faster time to market, improved competitiveness, and lower production costs. U.S. Food and Drug Administration (FDA) and international regulatory standards continue to evolve and become more stringent rules in Medical Devices. Validation & Verification (V&V) are required as part of designing and developing a medical device, as part of implementing a manufacturing production process or an automated system, as part of ensuring the appropriateness of a design, production or other process change, and as part of ensuring that a corrective or preventive action is effective and does not adversely impact product.