Safety & Efficacy Practices

We perform risk based evaluation & hence manage to reduce the risk to the most possible levels.  On the basis of risk based chart we identify the Hazard with respective severity/ consequence of Harm & their probability of reoccurrence.

• It is intended to have no risk remaining in the red region.
• All remaining risk shall possibly be in the green region.
• Risk remaining in the yellow region has to have a clear medical rational.
• Risks which  do  not  appear  in  the  acceptable  region  after  implementation  of  all  risk  control  measures  will  always  be communicated to and approved by the management.
• Any Risk remaining in the S-5 region will be specifically observed by post-market surveillance and the first occurring event is going to trigger an escalation plan.

• Design for intended use, Raw Material Selection, Storage & Preservation, Manufacturing Process & Control, Packaging, Labeling, Symbols, and Product Insert. Testing of critical parameters.
• Bioburden, Biocompatibility, Sterility, Toxicity, Pyrogenicity, Stability/Shelf Life, Hygiene of Products, adequate Labeling, and adequate Information have been carried out ethically.

• We perform the clinical evaluation in accordance with ISO 14155 & MEDDEV. 2.7.1 Rev.3; through the medical experts.
• Clinical evaluation data gathered in following ways
  • Literature review/Clinical Experience/Clinical Investigation
  • Comparison with Predicate Device
  • Customer complaints Review
• After gathering the enough information we perform Clinical data analysis & implement necessary changes if required & made final conclusion.
• As a supplementary to clinical evaluation we routinely perform the Post Market Clinical Follow Up.

A strong vigilance system helps us in performing the any reporting in very ethical way as per MEDDEV 2.12-1 rev 8 or as amended.