Mendtronix Inc. (MTI) announces the completion of the ISO 13485:2016/No Design certification
audit and official recommendation for certification. MTI expects official certification later in 2018.
The ISO 13485 standard is an effective solution to meet the comprehensive requirements for a Quality Management System (QMS). Adopting ISO 13485 provides a practical foundation for manufacturers to address the Medical Device Directives, regulations and responsibilities as well as demonstrating a commitment to the safety and quality of medical devices.
Official certification of ISO 13485 will help drive MTI’s growth as a Value Added 3PL providing logistical and technical services in the Medical Device industry.