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...
Phaco Emulsification Device
Cataract surgery is a procedure to remove natural but damaged cloudy lenses or cataracts from the ey...
Technical Biological and Clinical Characteristics
Demonstration of Equivalence in Technical Biological and Clinical Characteristics is important concl...
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...
Methodology for the Literature Search
Methodology for the Literature Search Scientific Literature is a permanent record of the collective ...
Clinical Evaluation Report Conclusions
Article 61 never gives a proper guidelines with respect to what and how a Clinical Evaluation Report...
Clinical Evaluation and Life Cycle of the Device
Clinical Evaluation Report documentation expected from the date of CE Certification. This means PMCF...
Sufficient Clinical Data
Confused about Sufficient Clinical Data as per MDR Article 61. If the manufacturer can demonstrate t...
Clinical Evaluation and Technical Documentation
Clinical Evaluation and Technical Documentation are interrelated in medical devices MDR compliance a...