Katrina Fiedler, Founder & Principal Consultant at WolfKat Regulatory Consulting, LLC, joins MIS Fractional as a lead consultant with extensive expertise in global regulatory affairs, quality systems, and compliance for the medical industry. Specializing in medical devices, IVDs, cosmetics, and OTC drugs, Katrina provides comprehensive support across the U.S., Europe, Canada, and Japan—from regulatory submissions to post-marketing vigilance. Her consulting services include:

• Global Regulatory Strategy: Developing and executing regulatory strategies for medical devices, IVDs, cosmetics, and OTC drugs in multiple regions.
• Quality Systems Implementation: Designing and implementing quality systems to meet international standards and ensure compliance.
• Regulatory Submissions: Managing submissions to regulatory bodies in the U.S., Europe, Canada, and Japan, ensuring timely approvals.
• Post-Market Vigilance: Overseeing post-marketing surveillance to maintain compliance and product safety.
• Compliance Support: Guiding clients through audits, inspections, and regulatory requirements to mitigate risks.