MAK & Associates – Service Offerings

  1. Regulatory Compliance Consulting
    • Expert guidance on FDA, ISO 13485, MDR, and global regulations.
    • Tailored strategies for medical device startups to achieve market readiness.
  2. FDA U.S. Agent Service
    • Act as your official U.S. FDA Agent to facilitate communication and regulatory submissions.
    • Ensure compliance with U.S. medical device registration and reporting requirements.
  3. Verification & Validation (V&V)
    • Development of risk-based verification and validation plans for medical devices.
    • Execution and documentation to meet FDA and international regulatory standards.
  4. Complaint & Adverse Event Reporting
    • Implementation of complaint management systems for FDA and EU regulatory compliance.
    • Adverse event reporting, including MDR and vigilance submissions to the FDA and EU authorities.
  5. Post-Market Surveillance & Trend Analysis
    • Support with PMS, PSUR, and PMCF activities to ensure ongoing safety and compliance.
    • Trend analysis to identify potential risks and prevent issues before they escalate.
  6. Quality Management Systems (QMS) Setup
    • Implementation of ISO 13485-compliant QMS tailored to your company’s size and needs.
    • Ongoing maintenance and auditing to ensure compliance with regulatory standards.

Each service is designed to streamline compliance, reduce risk, and accelerate your medical device’s time to market. Let’s ensure your success in the regulatory landscape today!