Profile Details

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Hire Dr. Ark K.

Germany

USD 10 /hr

FDA 510k eStart submission strategy and documentation - EU MDR compliance and ISO 13485 quality management systems

Profile Summary

I am a PhD-qualified molecular biologist with over 20 peer-reviewed publications and scientific books. For the past 8 years, I’ve worked in the medical device industry, specializing in international regulatory affairs—particularly FDA submissions. My core expertise lies in preparing and finalizing 510(k) submissions, including eSTAR formatting, in full compliance with current FDA guidelines. In addition to FDA regulatory support, I offer consulting services for EU MDR compliance and ISO 13485 quality management systems, helping companies align with global standards and streamline their product development and approval processes. Whether you're a startup navigating your first regulatory pathway or an established company optimizing your documentation, I provide precise, science-driven support to help you meet international regulatory requirements efficiently.

Subject Matter Expertise

• ☆ Medical Devices
• ☆ Medical Device Regulatory Consulting
• ☆ European Medical Device Regulation (MDR)
• ☆ ISO 13485
• ☆ ISO 14971
• ☆ EU In vitro Diagnostic Regulation (IVDR) Compliance
• ☆ Medical Equipment & Supplies

Services

• Writing
• Consulting

Consulting Healthcare Consulting

Work Experience

Postdoc

Universität Bielefeld

May 2025 - Present

QMR

CNSAC Germany

February 2008 - Present

Regulatory

SOMNOmedics GmbH

November 2007 - February 2008

Education

Research Fellow

Humboldt Universität Berlin - Germany

July 2010 - September 2012

PhD

Bielefeld University

May 2005 - June 2009

Certifications

• Risk Management Medical Device

  MDC

  November 2023 - Present

• Post-Market Surveillance

  MDC

  June 2023 - Present

• Medical Device Consultant

  Trautman

  May 2023 - Present

• MDR

  MDC

  April 2022 - Present

• PRRC MDR

  Trautmann

  January 2022 - Present