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Postmarket Medical Device Activities:

You have successfully entered the marketplace, but conditions are constantly changing and your ability to maintain product viability is regularly challenged. Perhaps you are planning to expand your marketing, introduce enhancements or changes to your device, its labeling or instructions. You may be concerned about successfully managing your postmarket surveillance efforts. MDCI can help you to plan and manage all of these challenges. Our consultants have the knowledge and expertise necessary to help you to:

• Perform EU Vigilance Reporting
• Respond to FDA 483s and Warning Letters
• Develop effective and competitive regulatory strategies to address future product and labeling changes
• Prepare Traditional or Special 510(k)s for new devices or existing device modifications
• Assess and understand any applicable European Medical Device Directives and individual country requirements to support international market introductions
• Design, manage, and monitor any clinical studies you may need to support future submissions or to meet any post-market requirements
• Prepare your team for FDA inspections and registrar or Notified Body assessments
• Manage your post-marketing surveillance requirements, include complaint handling, medical device reporting (MDR), vigilance reporting, failure investigations, problem reporting and device tracking

Contact us to learn more about postmarket medical device activities.