February 2010 On February 5, FDA released its final guidance document on statistical aspects of the design and analysis of clinical trials for medical devices that use Bayesian statistical methods. Bayesian statistics is an approach for learning from evidence as it accumulates. In clinical trials, traditional (frequentist) statistical methods may use information from previous studies […]
<h1 class="entry-title">Author: <span class="vcard">ComplianceAcuity</span></h1>
Health Canada requests electronic filing of some device license applications
January 2010 Effective January 1, 2010, all Class IV medical device license applications should be submitted in both a paper and electronic format and be prepared using the specifications outlined in the December 14, 2009 guidance document “Preparation of a Premarket Review Document in Electronic Format for a Class IV Medical Device License Application”.
ComplianceAcuity complaint handling solution featured by F-D-C Reports
January 2010 The ComplianceAcuity complaint handling solution was featured by F-D-C Reports in “The Silver Sheet” in September 2006 after the process was implemented at a large international device manufacturer during a global quality system remediation campaign spurned by an FDA warning letter.
Health Canada intends to adopt GHTF Summary Technical Documentation (STED) format for class III and IV device applications
August 2009 The Therapeutic Products Directorate (TPD), Health Canada has announced that it intends to adopt the Global Harmonization Task Force’s STED guidance document published February 21, 2008 to encourage and support the global convergence of documentation requirements for medical devices. Adoption of the STED as a basis for demonstrating conformity to the Essential Principles […]