QARA ISO 13485 May 6, 2020 EU Quality Management System Certificate (QMS) The Notified Bodies follow the chapter I of Annex IX in MDR for the conformity assessment of the Qua... Read More
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 The Medical Devices Regulation (MDR) provides several conformity assessment routes that medical devi... Read More
ShareThoughts Post Market Surveillance March 20, 2020 PMS Medical Device PMS Medical Device Post market activities are critical to generate clinical data regarding the medi... Read More
ShareThoughts Biocompatibility Testing March 3, 2020 Medical Device Validation Services ... Read More
ShareThoughts ISO 13485 March 3, 2020 ISO 13485 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