QARA MDR CE MARKING April 23, 2020 CE Marking for Surgical Gowns and Drapes Is CE Marking for Surgical Gowns and Drapes Mandatory for exporting to Europe? Is the Surgica... Read More
QARA MDR CE MARKING April 1, 2020 EU Declaration of Conformity Medical Device EU Declaration of Conformity Medical Device states that the requirements specified in the regulation... Read More
QARA MDR CE MARKING April 1, 2020 MDR Conformity Assessment Routes Chapter V section 2 of MDR Conformity Assessment Routes based on article 52. Conformity assessment r... Read More
ShareThoughts Post Market Surveillance March 20, 2020 PMS of Medical Device PMS of Medical Device Post market activities are critical to generate clinical data regarding the m... Read More
ShareThoughts ISO 13485 March 3, 2020 Control of Outsourced Processes Procedure (EN) ISO 13485:2016 Control of Outsourced Process is manufacturer’s responsibilities don’t chang... Read More
I3CGLOBAL ISO 13485 February 24, 2020 Non Conformity (NC) Non Conformity in ISO 13485 Certification Body Audit A major nonconformity is can be a failur... Read More
ShareThoughts Post Market Surveillance February 5, 2020 Medical Device Post Market Surveillance Medical Device Post Market Surveillance is normally performed after the medical device is released i... Read More
ShareThoughts ISO 14971 February 1, 2020 EN ISO 14971:2012 is Harmonized with MDR 2017/745 It is assumed that ISO 14971 will continue to be an international standard for medical device risk a... Read More