Regulatory Expertise

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.

Leverage Minnetronix’ Extensive Medical Device Regulatory Expertise

Since our founding in 1996, Minnetronix has continued to build upon our experience in regulatory affairs. Our deep 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. Our team's depth of knowledge and experience provides an excellent sounding board and resource for independent guidance. Minnetronix can provide regulatory strategy for both FDA submissions as well as Technical Files and Design Dossiers for CE submissions.

Count on Minnetronix’ Up-to-Date Knowledge of Agency Activities

Minnetronix tracks all highly visible FDA activities, and we pay particular attention to the guidance and draft guidance documents because of their immediate impact on our customers and the medical device industry. Guidance documents provide industry direction as well as convey current thinking of the FDA’s Center for Devices and Radiological Health (CDRH). Minnetronix reviews documents as they are released and provides information to our customers regarding possible impacts on internal processes or to any development and manufacturing projects. Just as we monitor the FDA, we also monitor the EU and other major countries’ regulatory activities.

Trust in Minnetronix' Regulatory Support

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 formatted in such a way that they 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 that was completed by Minnetronix.

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. All information can be accessed via Vital Link directly by the customer, or Minnetronix can help the customer navigate and obtain the information on Vital Link. 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.

Depend on Minnetronix' Compliance Expertise

  • International Harmonized Standards

    Minnetronix is well-versed in all applicable International Harmonized medical device standards.

  • Restriction of Hazardous Substances (RoHS)

    Minnetronix has a fully-developed RoHS program and can provide a certificate for all RoHS compliant devices. Our design efforts result in RoHS-compliant designs.

  • Conflict Origin Minerals

    Minnetronix has a Conflict of Origin Minerals policy that can be provided to customers upon request. We manage our suppliers to meet the requirements of the policy.