Ensuring the Safety & Effectiveness of Medical Devices through the Utilization of Emerging Sterilization Technologies & Validation of Established and Novel Modalities while Addressing Increased Regulatory Scrutiny of Sterilization Practices & Residual Testing
Across the medical device industry, executives responsible for product sterilization are continually evaluating processes and the validation of sterilization modalities to ensure bioburden levels are in-line with risk-mitigated regulatory standards, while at the same time reducing cycle times, costs, and time to market. Manufacturers must take into account internal as well as external sterilization capabilities, environmental hazards including aseptic processing against terminal sterilization, while at the same time analyzing the appropriateness of the sterilization modality. As such, regulatory compliance with FDA, ISO and AAMI standards as well as the accurate validation of sterilization methods are at the forefront of consideration, especially given the increasing number of audits being conducted.
The Q1 Productions 3rd & 4th Semi-Annual Medical Device Sterilization Conferences will provide executives with an opportunity for open dialogue surrounding the increased regulatory scrutiny on sterilization and how medical device companies can incorporate novel sterilization practices to continue ensuring the safety and effectiveness of medical technologies. Sterilization Engineers and Microbiologists from the Medical Device industry will have the opportunity to discuss key concerns while learning new strategies and best practices for improving internal processes. From reviewing crucial regulatory concerns to working effectively with an internal R&D team, the Medical Device Sterilization & Microbiology Conference will allow for robust educational and networking opportunities.