Adherium Receives ISO 13485 Certification
Adherium (NZ) Limited (formerly Nexus6) has received ISO 13485 medical device quality management system certification for operations at its New Zealand head office.
ISO 13485 is an international quality management standard that covers all aspects of a medical device company’s operations from product development to manufacturing to customer support. It has similar requirements to the widely-used ISO 9001 but includes more rigorous criteria appropriate for manufacturers of medical devices.
Adherium’s certification covers design, manufacture and distribution of medical devices for medication adherence monitoring solutions. This quality system certification demonstrates that the company has established internal procedures to allow it to consistently meet safety, accuracy and reliability standards for its medical device products and related services.
ISO 13485 certification will also support Adherium in extending its range of existing product approvals into new markets. Existing regulatory approvals for the company’s products include the United States, European Union and Australia. ISO 13485 is a key requirement to achieving new medical device registrations that will enable the company to expand into additional international markets.
Dr Doug Wilson, Chairman of Adherium, said the certification demonstrates Adherium’s ability and commitment to addressing customer and regulatory requirements in the digital medication marketplace.
“Adherium’s pharmaceutical, disease management and research customers operate in a highly regulated healthcare environment. ISO 13485 certification demonstrates that Adherium can deliver products in accordance with such high standards.”
About Adherium (NZ) Limited
Adherium is a global leader in digital health technology which addresses sub-optimal medication use and remote patient management in chronic disease. The Company’s Smartinhaler products are independently proven to increase patient adherence to preventative therapies, leading to improved disease management and reduced downstream healthcare costs.