Complaints and Warranty Claims (October, 2016 – 5 Pages)
Category Archives: Medical Device Regulations
Essential Design Outputs
Essential Design Outputs (October, 2016 – 3 Pages)
MDR Exceptions and Variances
MDR Exceptions and Variances (September, 2016 – 1 Page)
Record Retention for Device Manufacturers
Record Retention for Device Manufacturers (September, 2016 – 5 Pages)
Setting Quality Objectives
Setting Quality Objectives (July, 2015 – 6 Pages)
Setting the Medical Device Lifetime
Setting the Medical Device Lifetime (May, 2013 – 3 Pages)
UDI Final Rule Timing
UDI Final Rule Timing (May, 2013 – 1 Page)
EU Publishes New List of Standards Harmonized to the MDD
EU Publishes New List of Standards Harmonized to the MDD (September, 2012 – 2 Pages)
Excel Spreadsheet Validation with Multiple Versions
Excel Spreadsheet Validation with Multiple Versions (October, 2011 – 4 Pages)
Understanding Standards Harmonized to the MDD
Understanding Standards Harmonized to the MDD (September, 2011 – 2 Pages)