MedRA Regulatory Consulting provides a full range of Regulatory, Quality, and Clinical consulting and contracting services to both U.S. and International medical technology companies.  Services include but are not limited to:

• Developing Pre/Postmarket Global Regulatory Strategies.
• Cybersecurity Regulatory Compliance.
• Global submissions to include 510(k), PMA, Postmarket PMA-S, Pre-Submission (and FDA Meetings), IDE, Design Dossier and Tech File (Technical Documentation).
  
• Design Control.
• QSR 820, ISO 13485, and EN/ISO/ASTM/IEC Standards.
• FDA Submissions and Supplements.
• European Technical Documentation and Notifications.
• Other Global Device Authorizations.

From Fortune 100 companies to start-up innovators, MedRA Regulatory Consulting can assist with regulatory affairs services and solutions to medical device manufacturers seeking device authorization.  We partner with clients to develop regulatory strategies, with the option to also provide hands-on support in obtaining and maintaining global marketing authorizations for product(s), and identify and communicate regulatory requirements in support of licensing of products.