Clinical Device Group is a consulting and contracting firm medical device pre-approval issues. We assist medical device and diagnostic companies on both sides of the Atlantic. In business since 1990, we offer a full range of contract research organization services, biological safety assessment services, training books and productivity tools. Our goal: to help you bring medical products to market, faster. Clinical Device Group's key capabilities include: pre-market assessment,  protocol reviews, statistical strategies, sample size calculation, regulatory applications, IDE510(k) and PMA support, investigational site monitoring, data entry, statistical analysis data management, final reports, investigational site audits, sponsor audits, medical device clinical research training in good clinical practices (GCP), clinical trials design, project management for clinical studies and more.