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Good Safety & Efficacy Practices

Safety & Efficacy Practices


We outsource biocompatibility testing as per ISO 10993 & according ISO10993 matrix by certified labs. We use only biocompatible material for each invasive device. Our products are Non –Toxic & Non-Pyrogenic.

Risk Management

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.

Flow for Evaluation are as
Estimate the risk
Evaluate the Risk
Risk Control Analysis
Implement the Risk Control Measures
Then any residual risks are deemed to be outweighed considering clinical benefits.
Risk Management Policy
  • 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.

Essential Requirement

Check list of Medical Device Directive 93/42/EEC as amended by 2007/47/EC are followed for complying the essential requirement.
Essential Requirement major criteria’s are as below
  • 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.

Clinical Evaluation

  • 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.