Ascom (US), has achieved ISO 9001 and ISO 13485 certification, which emphasizes meeting regulatory as well as customer requirements, risk management and maintaining effective 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 president and CEO Chad West said 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.
"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," West said.
Ascom is a provider of on-site wireless communications for hospitals and manufacturing industries.