To futher strengthen our growing team of experts and increase presence in the US, Qserve is happy to welcome Mindy McCann to its team. Mindy brings many years of industry and Notified Body experience in Regulatory Compliance, Quality and Clinical.
In her last position she was Sr. Director of International Regulatory Compliance at Transmedics in Andover, MA. In that capacity, she lead all aspects of regulatory compliance and approvals for countries outside the US, including interaction with Notified Bodies and other authorities, managing clinical studies, hosting audits, improving the quality management system, writing CER’s and technical dossiers.
Mindy has a MSc degree in Chemical Engineering with a minor in biomedical engineering. Following her graduation, she worked at W.L. Gore. After having developed a strong basis in industry, she moved to KEMA (now DEKRA) Notified Body, as a Primary Certification Manager (Head of Notified Body).
After DEKRA, she was VP Healthcare North America at SGS Notified Body, where she was responsible for medical device, healthcare, pharmaceutical and cosmetic certification business throughoutin North America including CE certification.
Jan van Lochem, CEO of Qserve says: "Mindy will bring a mix of both industry and Notified Body experience to Qserve and is a great asset for our team, both in terms of regulatory compliance, quality and clinical experience."
For more information, please see her profile.