Marie Dorat

In the fast-evolving medtech sector, maintaining compliance with regulatory standards is not just a requirement but a critical factor for sustainable growth. Over the past 25 years, I have partnered with small and mid-size businesses in regulated industries, helping them navigate the complexities of compliance with tailored solutions. One of the most effective ways to ensure quality and regulatory adherence is through well-designed Corrective and Preventive Action (CAPA) courses specifically...

Introduction: Where Fun Meets Form 483 in FDA Audits Picture this: you’re an auditor stepping into the high-stakes world of FDA, ISO 13485, and MDSAP audits. One undocumented deviation can send a medical device company into regulatory orbit. Audits have a reputation for being tense, awkward, and about as fun as a surprise root canal—but they don’t have to be. Think of this article as your witty roadmap to surviving (and even enjoying) the human side of audits. We’ll cover understanding...

June 2025, the FDA finalized guidance on Post-Warning Letter Meetings under GDUFA III, following its September 2023 draft. The guidance, titled “Post-Warning Letter Meetings(PWLM) Under GDUFA,” outlines the process for requesting and conducting meetings to address current good manufacturing practice (CGMP) deficiencies cited in FDA warning letters. Although, primarily aimed at generic drug manufacturers, the guidance offers valuable insights for all FDA-regulated industries, including...