Medfield Diagnostics has recently been reviewed and received its ISO 13485 certificate by the accredited certification company Intertek. ISO 13485 is an international standard for quality management linked to the development, marketing and sale of medical devices. The standard describes the processes, documentation, required to provide medical devices to the healthcare industry.
“Quality management is a central part of our business, and a prerequisite to effectively ensure the quality and safety of our products,” said Medfield’s CEO Dag Jungenfelt. “ISO certification is an acknowledgment that Medfield live up to the high requirements for medical devices and also an important step towards CE marking of the company’s first product, Strokefinder MD100.”
ISO 13485 is based on the more general ISO 9001, but has higher requirements on formal documentation and product safety. The standard is well established and accepted by the market worldwide.
Questions answered by Dag Jungenfelt, CEO Medfield Diagnostics AB, tel. 070-987 28 27 or email@example.com
Intertek is a leading provider of quality and safety solutions with over 36,000 employees in 100 countries (http://www.intertek.se)