We are proud to announce that Napier Healthcare has joined the ranks of the elite group of companies who are certified as EN ISO 13485:2012 compliant. This certification is the best internationally-accepted model an organization can implement to help demonstrate compliance with laws, regulations and quality standards of the medical device industry including key medical software and applications.
As an ISO 13485 certified company and product, our customers and partners can improve safety and reliability, minimize the risk and maximize the quality of the product. Napier is the thought leader in having world-class ISO 13485 compliant products for chronic care management, vitals management, aged care and community care. In the case of Napier’s Remote Patient Monitoring (RPM) solution, the performance and effectiveness of the solution depend on how the patient data from medical devices is being collected, transferred and monitored. Safety and quality of medical devices used in the solution are non-negotiables in the healthcare industry. Regulatory requirements are increasingly stringent throughout every step of a medical device lifecycle.
In response to this market need, Napier developed comprehensive quality processes to achieve compliance to the ISO standard. Some of these processes were to document policies for record controls, internal auditing procedures, non-conformance controls, preventative and corrective actions, process and design controls, accountability and traceability. Risk management was thoroughly documented and conducted throughout RPM’s entire lifecycle, from initial concept to delivery and post-delivery.
Our customers, partners, and users are the key beneficiaries of this certification – They can communicate a commitment to quality to both patients and regulators. Organisations can establish credibility and compete effectively with the properly implemented and maintained a system which meets the government quality and regulatory requirements. With this compliance in place, providers can increase their access to more markets and produce quality outcomes.
—By Venkappa Sirigiri, Business Analyst, Napier Healthcare Solutions (firstname.lastname@example.org)