Regulatory and Compliance Team
The R&C team consists of experienced individuals who are responsible for establishing Cognos’ business and industry regulatory standards in order to ensure complete compliance with all required, state and federal, and global bodies whose governance impacts both the business and medical device arenas in which Cognos operates. In addition, the team is responsible for assuring the pathways to regulatory certification in order to be able to safely enter the targeted marketplaces have been followed and that all needed certification has been obtained and is maintained.
Dr. SUSAN ALPERT, MD, PhD
Lead Regulatory for USA
Dr. Alpert brings over three decades of experience in helping organizations like the FDA, Medtronic and Accelmed in setting and achieving the standards of compliance for regulatory acceptance of advanced medical technologies.
Jaap Laufer, MD, PhD
Lead Regulatory for EU CE-Mark
Dr. Jaap Laufer has over 30 years of regulatory and clinical experience specializing in implant device and combination product submissions for FDA QSR compliance and clinical study submissions and compliance.
Lead Regulatory Firm
MCRA is a leading multi-service integrated business that assists in the entire technology life cycle, from research and development, through commercialization. MCRA has more than 150 years of combined expertise lies in clinical research, clinical reimbursement, regulatory and compliance
Manager, Special Medical Device Regulatory and Compliance
Darci Diage has over 18 years of experience in the medical device industry focusing on manufacturing, design control, risk management and concept to commercial product development activities including preclinical and clinical submissions.