Non Conformity (NC)
Non Conformity in ISO 13485 Certification Body Audit A major nonconformity is can be a failur...
Medical Device Post Market Surveillance
Medical Device Post Market Surveillance is normally performed after the medical device is released i...
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 ...