{"id":3900,"date":"2014-05-31T19:35:45","date_gmt":"2014-05-31T19:35:45","guid":{"rendered":"http:\/\/www.eisnersafety.com\/eisnersafetycom\/?p=3900"},"modified":"2014-05-31T19:35:45","modified_gmt":"2014-05-31T19:35:45","slug":"bsi-white-paper-on-generating-clinical-evaluation-reports","status":"publish","type":"post","link":"https:\/\/eisnersafety.com\/eisnersafetycom\/2014\/05\/31\/bsi-white-paper-on-generating-clinical-evaluation-reports\/","title":{"rendered":"BSI White Paper on Generating Clinical Evaluation Reports"},"content":{"rendered":"

\"\"<\/a>Blog focus BSI\u2019s 2nd<\/sup> in a series of White Papers for Medical Device & IVD industries, on Generating clinical evaluation reports<\/span><\/p>\n

White Paper on Generating clinical evaluation reports<\/strong><\/strong><\/span><\/h2>\n

This white paper is on \u201cGenerating clinical evaluation reports – A guide to effectively analysing medical device safety and performance<\/a><\/strong>\u201d and is focused on \u201c\u2026guidance on how to satisfy important regulatory requirements e.g. the concept of equivalence and post-market clinical follow-up (PMCF).\u201d \u00a0It is written by Dr Hassan Achakri, PhD, Director, International Clinical Affairs, Zimmer GmbH; Peter Fennema, Director, AMR Advanced Medical Research; and Dr\u00a0Itoro Udofia, PhD, Orthopaedic & Dental Team Leader, BSI<\/a><\/strong>\u00a0.<\/span><\/p>\n

I have the distinct pleasure and honor of assisting BSI review this white paper as a member of the BSI Medical Devices White Paper Advisory Panel for this series of white papers.
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White Paper Series and Future Topics to Come<\/strong><\/strong><\/span><\/h2>\n

BSI says of this series that “Throughout the year, we are going to be producing a series of medical devices white papers. These will keep you up to date with regulations, developments and help you prepare for changes within your industry.\u201d<\/span><\/p>\n

The additional white papers in the series will be on:<\/span><\/p>\n