Minnetronix' proprietary electronic quality system meets medical device industry standards. Our processes help you mitigate risk and comply with FDA and international regulations.
Mitigate Risk with Minnetronix’ Quality Management System (QMS)
Our quality management system encompasses design, development, manufacturing, commercialization, and service of medical electronic and electromechanical products. The Minnetronix Quality Management System (QMS) is a true Original Equipment Manufacturer (OEM) medical device QMS and meets all of the requirements of the medical device regulations. Our QMS is based on continually improving our development, manufacturing, and business processes.
Our structured and agile quality system allows us to tailor our services to meet individual program needs and to achieve the best outcomes for your business.
Minnetronix has undergone six successful FDA Quality System Inspection Technique (QSIT) inspections with No Action Indicated (2016, 2015, 2010, 2008, 2004 and 2001). In a typical year, our QMS is subjected to more than 30 audits by regulators and customers.
We measure and track defined objectives and metrics to ensure compliance for each of our major business functions.
The Minnetronix QMS meets these standards:
- Minnetronix incorporates the process approach identified in ISO 9001:2008 and ISO 13485:2003 into the QMS to produce quality products.
- Minnetronix has established, documented, and maintains an effective QMS that meets the requirements of ISO 9001:2008, ISO 13485:2003, and the FDA Quality System Regulation (QSR).
- The Minnetronix Risk Management System is compliant to ISO 14971.
- The Minnetronix Software Development Process meets the requirements of IEC 62304.
Enable Superior Communication through Vital Link
Minnetronix is committed to efficiency, effectiveness and outstanding communication with our clients. We utilize state-of-the-art systems in a high-tech environment and continually invest in sophisticated tools to minimize any barriers to development.
The Minnetronix Electronic Data System (MEDS) is a proprietary data management system used in the execution of our QMS. MEDS provides for the storage, maintenance, and retrieval of electronic records and supports electronic signatures. The system is verified and validated to meet the requirements of the QSR for software validation. MEDS is also 21 CFR Part II (Electronic Records and Electronic Signatures) compliant.
Vital Link, our proprietary customer portal for MEDS, is a sophisticated, web-based system that allows you, as our customer, access to the electronic records such as the design history file (DHF) and the Device Master Record (DMR) for specific projects.
Minnetronix Quality Policy
- We are dedicated to helping our customers succeed.
- We contribute to their success by providing technical expertise for developing and manufacturing medical devices.
- We believe in maintaining an effective Quality Management System that is based on continually improving our development, manufacturing and business processes and meets regulatory requirements.