ShareThoughts MDR CE MARKING October 3, 2019 Phaco Emulsification Device Cataract surgery is a procedure to remove natural but damaged cloudy lenses or cataracts from the ey... Read More
QARA Clinical Evaluation October 2, 2019 Technical Biological and Clinical Characteristics Demonstration of Equivalence in Technical Biological and Clinical Characteristics is important concl... Read More
QARA Clinical Evaluation July 2, 2019 MEDDEV 2.7/1 Revision 4 Clinical Evaluation Plan It is one of the requirement of MDR to have a “CLINICAL DEVELOPMENT PLAN” as part of “Clinical... Read More
QARA Clinical Evaluation June 2, 2019 Methodology for the Literature Search Methodology for the Literature Search Scientific Literature is a permanent record of the collective ... Read More
QARA Clinical Evaluation April 2, 2019 Clinical Evaluation Report Conclusions Article 61 never gives a proper guidelines with respect to what and how a Clinical Evaluation Report... Read More
QARA Clinical Evaluation March 2, 2019 Clinical Evaluation and Life Cycle of the Device Clinical Evaluation Report documentation expected from the date of CE Certification. This means PMCF... Read More
QARA Clinical Evaluation January 2, 2019 Sufficient Clinical Data Confused about Sufficient Clinical Data as per MDR Article 61. If the manufacturer can demonstrate t... Read More
QARA Clinical Evaluation December 2, 2018 Clinical Evaluation and Technical Documentation Clinical Evaluation and Technical Documentation are interrelated in medical devices MDR compliance a... Read More
QARA Clinical Evaluation November 10, 2018 Significance of Equivalent Device Significance of Equivalent Device in new MDR 2017/745 Medical Device CE Marking A CE marked d... Read More