Validations [(Sterilization validation – ETO, Gamma, Moist heat), Packaging validation, Special manufacturing processes (Anodizing, Electro-polishing, Ultrasonic cleaning, Cleaning validation, Software, crimping and Equipment validation), Clean room validation]
U.S. Food and Drug Administration (FDA) and international regulatory standards continue to evolve and become more stringent. 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.
With the highest number of medical device experts and the widest service offering MAVEN assists you in preparing the protocols and reports for establishing your process giving consisting quality outputs throughout your device manufacturing stage and establish the frequency of revalidations.