Sarah Stec

Sarah H. Stec

Associate

Sarah is an associate in the Healthcare Practice in Washington DC. She has experience in assisting healthcare and life sciences companies understand new and evolving regulatory duties, including how those international regulations can work together as well as providing guidance on international corporate accreditation and regulatory issues.

Explore

  • Monitoring worldwide regulatory developments and providing regulatory updates and addressing compliance obligations and emerging industry developments.
  • Translating the EU and FDA pre-approval, clinical trial, Research Use Only, Investigative Device Exception and other regulations for clients on both sides of the Atlantic to provide regulatory guidance and help clients develop regulatory strategies.
  • Primary resource for guidance on EU Medical Devices Directive (93/42/EC), Active Implantable Medical Devices Directive (90/385/EEC), In Vitro Diagnostic Medical Devices Directive (98/79/EC), ISO 13485, and others, and how they compare with US FDA 510(k) and PMA regulations, US FDA Quality System regulations, Universal Device Identifier regulations, labeling and advertising laws.
  • Interfacing with international regulators for questions concerns regarding client products.
  • Identifying and manage front-end research for all new domestic and international corporate accreditations, including OSHA NRTL, INMETRO (Brazil), COFEPRIS (Mexico).
  • Analyzing impacts of new notified body regulations on production capacities and bottom line.

Education

  • Pennsylvania State University, J.D., 2010
  • Loyola University Chicago, B.A., Honors, 2006

Admissions

  • Virginia, 2011
  • Not admitted in the District of Columbia; practice limited to matters pending at federal courts and agencies.

Memberships and Affiliations

  • Member of the Regulatory Affairs Professionals Society (RAPS) 
  • Member of the Food and Drug Law Institute (FDLI)

Languages

  • English
  • French

{{insights.date}} {{insights.source}} {{insights.type}}

  • Moderator, “Common Challenges Facing Lawyers in our Globalized Medical Products Industry, Parts 1 and 2; Advertising, Promotion, and the Sunshine Act,” RAPS Regulatory Convergence, October 2015. 
  • Author, Chapter on Enforcement and National Authorities, Fundamentals of EU Regulatory Affairs, 7th Edition. 
  • Presenter, “EU IVD Regulatory Evolutions on Performance Evaluations and Post-Market Surveillance,” Q1 Clinical Affairs and Regulatory Approvals for Diagnostics Conference, October 2015.
  • Presenter, “Update on EU IVD and Medical Device Regulations,” BioOhio conference, Columbus, OH, September 2015.