Ensure Regulatory Compliance with Expert Complaint & Adverse Event Management

Managing medical device complaints and adverse event reporting is a critical part of regulatory compliance. Proper handling not only ensures patient safety but also protects your company from potential enforcement actions. At MAK & Associates, LLC we provide a comprehensive complaint and adverse event reporting service to help medical device manufacturers comply with FDA, MDR (EU), and other global regulatory requirements.

Our Services Include:

✅ Complaint Handling & Investigation

  • Establish a robust complaint-handling system aligned with FDA 21 CFR 820.198, ISO 13485, and EU MDR requirements.
  • Assess complaints for reportability and ensure proper categorization.
  • Conduct thorough investigations, including root cause analysis and corrective actions.

✅ Medical Device Reporting (MDR) & Vigilance Submissions

  • Determine if complaints qualify as Medical Device Reports (MDRs) for the FDA.
  • Prepare and submit FDA Form 3500A for adverse event reporting.
  • Assist with EU vigilance reporting (MIR) for incidents requiring Competent Authority notification.

✅ Post-Market Surveillance (PMS) & Trend Analysis

  • Develop and maintain Post-Market Surveillance Plans (PMSP).
  • Perform trend analysis to detect potential safety risks before they escalate.
  • Support Periodic Safety Update Reports (PSURs) and Post-Market Clinical Follow-up (PMCF) activities.

✅ Recall & Field Action Support

  • Assess the need for recalls, corrections, and removals based on complaint data.
  • Coordinate communication with the FDA, EU Competent Authorities, and other regulators.
  • Develop and implement corrective and preventive actions (CAPA) to prevent recurrence.

✅ Audit Readiness & Compliance Support

  • Ensure your complaint and reporting processes meet FDA and international regulatory standards.
  • Assist with FDA inspections and Notified Body audits related to post-market surveillance.
  • Provide training for teams on complaint handling best practices.

Why Choose MAK & Associates?

✔ Regulatory Expertise: Over 30 years of experience in FDA, ISO 13485, and MDR compliance.
✔ Efficient & Compliant Reporting: Avoid penalties and delays with accurate and timely submissions.
✔ Proactive Risk Management: Identify and address potential issues before they escalate.
✔ Tailored for Startups & Global Manufacturers: Scalable solutions for companies of all sizes.

Let’s Simplify Compliance for You!

Don’t let complaints and adverse event reporting become a regulatory burden. Contact MAK & Associates, LLC today to ensure compliance and patient safety with our expert reporting services.

📩 Get in touch now to discuss your needs!