On-Demand Webinar

Digital Transformation: Turning Medtech Compliance into a Competitive Edge

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Hear Cook Medical, Exact Sciences, and NNIT share best practices on how companies can better support digital initiatives, turning compliance into a competitive edge.

The medtech industry is facing a more complex regulatory landscape than ever before. To ensure ongoing compliance, patient safety, business longevity, and competitive advantage, medtech companies should embrace digital transformation, which allows organizations to support cross-functional data efficiency, increase 24/7 insights, reduce compliance challenges, and speed time to market. However, the selection and adoption of digital technologies require focus and thorough analysis.

Watch this webinar to learn:

  • Successful approaches to digital transformation
  • The role of technology in shifting from reactive to proactive approach
  • What to look for in a digital solution to support sustainable compliance globally


Françoise Schlemmer

Director Global Regulatory Affairs

Cook Medical

Sinéad leads the regulatory affairs function for the largest family-owned global medical technology company Cook Medical. Based in Limerick, Ireland, she has over 25 years of experience in the medtech and pharma industries and is committed to driving regulatory excellence through cross-functional collaboration and continuous improvement. Sinèad is responsible for over 270 regulatory affairs employees globally, is currently the global lead for Cook Medical for EU MDR, and her previous positions were in the areas of pharma manufacturing, start-up and validation. As part of her current role, she is completing a digital transformation of Cook Medical’s regulatory affairs systems and processes.

Kelly Barbeau

Senior Regulatory Affairs Specialist

Exact Sciences

Kelly has more than 15 years of experience in biotechnology including research, manufacturing, quality control, and clinical trial management. As Senior Regulatory Affairs Specialist with Exact Sciences, she is focused on maintaining regulatory compliance and producing high caliber regulatory filings. Prior to Exact Sciences, Kelly held regulatory affairs and clinical trial positions with Luminex Corporate and Stratatech Corporation.

Niels Buch Leander

Associate Vice President Regulatory Affairs Advisory & Consulting


Niels Buch Leander has more than13 years of experience in the digital transformation of Regulatory Affairs. Niels is active in the EMA SPOR task force and has worked for several of Europe’s top life science companies, providing consultancy, project management, and advisory. Niels’s specialties are within regulatory affairs transformation, moving from documents to structured data, from silo application landscapes to unified platforms by introducing the next waves of RIMS, EDMS solutions, etc.

Brian Scogland

Director Regulatory Strategy

Veeva MedTech

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