What We Do

Global penetration demands that U.S. medical device manufacturers confront a continually changing EU regulatory landscape and gain entry into country sensitive approval pathways. MMC can assist in establishing a working link between parties to achieve mutual goals.

Our clients, U.S. device manufacturers, rely on us to find suitable international partners for marketing, clinical agendas, and eventual distribution of their medical devices in small but key markets.

The mission is early adoption and to successfully establish long term and profitable business relationships in a global medical community.

The Clinical Team

MMC Complete Clinical Support Services

• Study protocol development and design
• Case report design
• Clinical research support
• Investigator collaboration and on-site support
• Study monitoring
• Site management
• Protocol adherence monitoring
• Clinical device development to implementation
• Device training and teaching manuals
• Global Database of clinical technicians, study monitors and investigators

MMC Clinical Trial Responsibilities and Sponsor Support

• Generate and update clinical protocol
• Interact with regulatory agencies (directly or through regulatory agencies)
• Maintain regulatory agency and hospital approvals for study
• Control product distribution
• Maintain study database
• Assist in Legal Representation
• Identify Clinical Monitor and Clinical Specialists
• Investigate device-related adverse events
• Follow-up device-related adverse events
• Follow-up protocol deviations

MMC Clinical Monitors & Specialists

• Establish contact with investigators
• Interact with Notified Bodies and Local EC to obtain required approvals
• Maintain file of investigator agreements, patient consent forms and CRF's
• Establish contact and interact with Hospital Study Coordinator
• Note and communicate protocol deviations to Sponsor and Notified Bodies