Biological and Clinical Characteristics
Understanding the complex interplay of health and illness in the human body is based on biological a...
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...
Significance of Equivalent Device
Significance of Equivalent Device in new MDR 2017/745 Medical Device CE Marking A CE marked d...
Clinical Investigation and Post Market Clinical Follow Up
Clinical Investigation and Post Market Clinical Follow Up along with Post Market Surveillance should...