Minnetronix Quality Management System (QMS)
Our quality management system encompasses design, development, manufacturing, commercialization, and service of electronic and electromechanical medical devices. The Minnetronix Quality Management System (QMS) meets all requirements of the medical device regulations.
Minnetronix Quality Policy
Minnetronix Product Development Process
The Minnetronix Product Development Process (PDP) is designed for speed and agility. It is based on phase gate methodology to drive consistency in execution but also incorporates a Tracks Model concept to support varying customer needs using multiple development tracks.
Perfect Record for FDA Quality System Inspection Technique (QSIT) inspections
Minnetronix has undergone eight successful FDA Quality System Inspection Technique (QSIT) inspections with No Action Indicated (2018, 2017, 2016, 2015, 2010, 2008, 2004 and 2001). In a typical year, our QMS is subjected to more than 30 audits by regulators and customers.
Certificates and Compliance to Standards
The Minnetronix QMS meets these standards:
- ISO 13485:2016 – Medical Devices – Quality Management Systems
- 21 CFR Part 820 – FDA Quality System Regulation (QSR)
- ISO 14971:2012 – Medical Devices – Application of Risk Management
- IEC 62304:2015 – Medical Device Software – Software Lifecycle Processes
Superior Communication with Vital Link
Minnetronix is committed to efficient and effective 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 provides customers with secure 24/7 access to their electronic records such as design history files (DHF) and Device Master Records (DMR). Although many companies have an electronic data management system for their customers, it is the breadth of Vital Link that makes it unique. Auditors have called MEDS and Vital Link “a benchmark in electronic record keeping.”
Learn more about Vital Link
MEDICAL DEVICE SERVICES: Regulatory Support
Minnetronix offers exceptional medical device Regulatory Affairs expertise. We assist our customers in mitigating risk and complying with FDA and international regulations through effective and efficient processes.
Our deep regulatory expertise ensures your device meets the most current performance and quality standards of the medical device industry. Minnetronix conducts a high-level assessment of your regulatory strategy and provides input into your regulatory path for FDA and CE submissions. Our team’s depth of knowledge and experience provide an excellent sounding board and resource for independent guidance.
Minnetronix can help you with a wide spectrum of communications to the FDA or other notified bodies, including responses to submissions, inspections, and audits.Minnetronix provides design outputs that can be incorporated directly into your submission. Our substantial experience with FDA meetings and the IDE, PMA and 510k processes is a valuable resource available to you. In addition, we can provide detailed responses to the FDA or notified bodies for work completed by Minnetronix.
FDA and Notified Body Inspections
Minnetronix can help support FDA and notified body inspections through Vital Link, our proprietary customer portal. Customers can access all necessary objective evidence needed by FDA or a notified body during an inspection. Minnetronix manages inspections that occur on-site at Minnetronix or at one of our suppliers. We provide a detailed debrief of the inspection for those items that are directly applicable to you.
- Registration, Evaluation, Authorization and Restriction of Chemicals (REACH)
- Restriction of Hazardous Substances (RoHS)
- Conflict Origin Materials
- International Harmonized Standards