プロフィール詳細

プロジェクトを作成

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Dr. Ark K.に依頼

Germany

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

プロフィール概要

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.

専門分野

• ☆ 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

サービス

• Writing
• Consulting

Consulting Healthcare Consulting

職務経験

Postdoc

Universität Bielefeld

5月 2025 - 現在

QMR

CNSAC Germany

2月 2008 - 現在

Regulatory

SOMNOmedics GmbH

11月 2007 - 2月 2008

学歴

Research Fellow

Humboldt Universität Berlin - Germany

7月 2010 - 9月 2012

PhD

Bielefeld University

5月 2005 - 6月 2009

認定資格

• Risk Management Medical Device

  MDC

  11月 2023 - 現在

• Post-Market Surveillance

  MDC

  6月 2023 - 現在

• Medical Device Consultant

  Trautman

  5月 2023 - 現在

• MDR

  MDC

  4月 2022 - 現在

• PRRC MDR

  Trautmann

  1月 2022 - 現在