Non Conformity in ISO 13485 Certification Body Audit   A major nonconformity is can be a failure of the  following: Read More

Medical Device Post Market Surveillance is normally performed after the medical device is released in market with CE Mark affixed Read More

It is assumed that ISO 14971 will continue to be an international standard for medical device risk analysis and EN Read More

Cataract surgery is a procedure to remove natural but damaged cloudy lenses or cataracts from the eye to improve vision. Read More

Demonstration of Equivalence in Technical Biological and Clinical Characteristics is important concluding a CER.   Question 01: Technical characteristics include Read More

It is one of the requirement of MDR to have a “CLINICAL DEVELOPMENT PLAN” as part of “Clinical Evaluation”. A Read More

Methodology for the Literature Search Scientific Literature is a permanent record of the collective achievements based on the research, and Read More

Article 61 never gives a proper guidelines with respect to what and how a Clinical Evaluation Report Conclusions should be!! Read More

Clinical Evaluation Report documentation expected from the date of CE Certification. This means PMCF and PMS start in the same Read More