Feb 17 2011
Ascom (US) Inc., is proud to announce that it has achieved ISO 9001 and ISO 13485 certification. ISO 13485 emphasizes meeting regulatory as well as customer requirements, risk management and maintaining effective processes, namely the processes specific to the safe design, manufacture and distribution of medical devices. Although ISO 13485 compliance is voluntary, it provides a framework for meeting medical device quality requirements in the international market. Compliance with ISO 13485 helps meet the requirements outlined in 21 CFR Part 820 for the Quality System Regulations (QSR) applicable to medical device manufacturers and importers.
"Ascom decided to take the proactive route and implement a Quality Management System (QMS) to ensure that our products and processes were in place to meet or exceed proposed guidelines and rules" states Chad West, President and CEO of Ascom (US) Inc. "Our healthcare customers are demanding that their vendors are compliant with regulatory requirements that ensure the safety of their patients by providing products that are thoroughly designed, tested, verified, validated and implemented using a structured QMS throughout all departments within their organizations."
Ascom has become the leader in medical system integrations by delivering secondary alerts and messages with wireless technology to mobile care givers. Regulatory bodies have been reviewing their guidelines and policies regarding the storage and wireless transfer of medical data for the past several years. Worldwide, there is a growing trend to improve the quality of medical devices through medical device regulations.