Frank Maier provides operational leadership and functional oversight of Project Management, specializing in medical device and IVD studies. He has more than 15 years of CRO experience managing international clinical investigations, spanning a wide range of therapeutic areas and study designs. He is an expert in applying regulatory requirements such as ISO 14155, ISO 20916, (EU) MDR 2017/745, (EU) IVDR 2017/746, relevant MDCG guidelines and GDPR. Frank has experience in pre- and post-market clinical investigations including EU-wide submissions and provides effective leadership to teams and excels in strategic planning and creative problem-solving. He participates in inspections and audits, including conducting ISO 14155 audits of customers. Frank holds a Specialized Registered Nursing degree in intensive care.
