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Scott is a veteran regulatory affairs executive with a proven track record in successful global regulatory strategies.
Scott leads the atHeart Medical regulatory affairs team with over two decades of regulatory affairs leadership experience. His expertise includes developing and implementing global regulatory strategies including CE Marking, IDE, 510(k), PMA and de novo clearances. He has provided regulatory leadership for large-scale clinical studies and managed teams in executing international regulatory strategy expansions. Previously, he held senior regulatory roles with Cala Health, Twelve (MDT), Ardian (MDT), Radiant Medical and Edwards Lifesciences. Scott holds a Bachelor of Arts in Political Science and German from UC Berkeley and a PhD in Political Science from UC Santa Barbara.
SIMONA WIEDMER / HEAD OF OPERATIONS
Simona is skilled at transitioning medical device innovations from prototype to production.
Simona leads the atHeart Medical operations team with over a decade of medical device engineering experience. Her expertise includes development of device requirements in collaboration with key medical stakeholders and the design and execution of feasibility testing strategies. Simona has played a key role in project management from prototype to production and led the preparation of technical documentation in support regulatory submissions for several innovative medical technologies. She has a Bachelor of Science in Microengineering and a Master of Advanced Studies in Medical Technology from the Bern University of Applied Sciences in Bern, Switzerland.
STEFFEN STANDFUSS / HEAD OF QUALITY
Steffen brings a strong strategic background and deep knowledge of industry quality standards.
Steffen leads the atHeart Medical quality team with over twenty years of medical device quality management experience. He brings a strong background of strategic thinking and deep knowledge of industry standards to ensure product safety and effectiveness. Steffen’s expertise has driven key process improvements related to design verification and validation, design control, change management and corrective and preventive actions management. He has held roles of increasing responsibility with Biotronik AG, Edwards Lifesciences AG, Skan AG, and Abbott Laboratories. Steffen has a degree in mechanical engineering from the University of Karlsruhe, Germany, and a PhD in Aerodymics from the Cranfield University in the UK. Additionally, he holds a Six Sigma Green Belt and is PRINCE2 Practitioner certified.
AJIT MALLIK / MD, PhD, HEAD OF EU REGULATORY
Ajit’s physician background provides a unique perspective bringing meaningful medical device technologies to market.
Ajit leads the atHeart Medical European regulatory team and brings a decade of experience in medical device regulatory leadership. He has extensive expertise in developing and executing complex global regulatory strategies and has worked with products in various stages of the development life cycle and across all medical device classifications, spearheading submissions that initiated clinical trials and successfully brought much needed innovations to market. Ajit is co-author on several peer reviewed publications and has numerous regulatory certifications in the U.S. and Europe. He holds an MD from SCB Medical College in India, a Master’s in Medical Science and Technology from the Indian Institute of Technology, and an MD PhD from the University of Zurich, Switzerland.
KUNO LIMACHER / HEAD OF R&D
Kuno led the development of the reSept ASD Occluder with his expertise in engineering and cardiovascular device design.
Kuno leads the atHeart Medical product development team with twenty years of medical device engineering experience. His efforts and leadership have been instrumental in the development of the reSept ASD Occluder since the inception of the device in 2007. Kuno is co-author on several peer-reviewed publications and co-inventor on seven published patents. He holds a Bachelor of Science in Mechanical Engineering and a Master of Science in Industrial Management and Manufacturing, with a specialization in biocompatible materials and product management, from ETH Zurich, Switzerland.
BRANDI SADOWSKI / VP CLINICAL AFFAIRS
Brandi is a seasoned clinical affairs leader with extensive experience building and executing successful clinical programs.
Brandi leads the atHeart Medical clinical affairs team with over twenty years of clinical affairs leadership experience. Her expertise includes overseeing global large-scale, multicenter randomized clinical trials, including both Investigational Device Exemption (IDE) and post-market studies. In addition to creating and implementing robust clinical programs, Brandi has played a key role in numerous regulatory submissions, strategic development, diligence, and fundraising efforts. Previously, she has held clinical leadership positions with innovative medical device companies such as EBR Systems, Cotera, Ivantis and Ardian. Brandi holds a Bachelor of Science in Genetics from the University of Wisconsin in Madison, WI.
LAURENT GRANDIDIER / CEO
Laurent is a global medtech executive with talent for turning research projects into commercially viable companies.
Laurent leads the atHeart Medical team with over fifteen years of experience in medical device development and commercial leadership. He is a veteran in innovative cardiovascular devices and brings a solid track record of successfully building and leading diverse, cross functional teams for both start-ups and Fortune 500 companies, including Xeltis, Endosense, Boston Scientific, Guidant, and Procter and Gamble. Laurent holds several independent board positions and has received numerous professional awards including the 2018 Outstanding Executive at the Global Business Excellence Awards and the Best European CEO in Medical Devices by European CEO Magazine in 2015. He holds a Master of Science in Computer Science from the National Institute for Applied Sciences in Lyon, France, and an MBA from INSEAD, France-Singapore.