Hyperbaric Oxygen Therapy- FDA

HBOT involves breathing 100% (pure) oxygen while in a special space called a hyperbaric chamber. The air pressure inside is raised to a level that is higher than normal air pressure. The FDA regulates both the oxygen used in HBOT and the hyperbaric chambers, which are generally a tube large enough to hold one person …

510(K) Clearance for Nitrile Examination Glove

Polymer Patient Examination Glove Device             :           Polymer Patient Examination Glove                                     Powder Free Nitrile Examination Glove Definition        :           A nitrile (or polymer) patient examination glove is a disposable device made of nitrile rubber or synthetic polymers that may or may not bear a trace amount of residual powder and is intended to be …

EU MDR Transport Validation Of Medical Device

Common expected questions are whether a non-sterile medical device expected to perform transport validation? Is it mandatory to perform transportation test under laboratories? Alternative methods for transport validations. Transport validations are performed to examine the suitability of packaging compatibility and safety.  The transportation and the storage must not affect the properties of medical device ie, …

An Overview of Medical Device Packaging Validation

Do you know why medical device packaging is so important? Usually proper packaging is required by the medical device is to avoid, physical damage, biological contamination, and any other external disturbance. The other motive is the proper identification of the device. The medical device packaging validations are mostly required for terminally sterilized medical devices. Because …

Risk Evaluation Approaches- ALARP Vs AFAP

As-Iow-as-reasonably-practicable approach(ALARP) - is that the residual risk shall be reduced as far as reasonably practicable and this approach can be used as part of risk control options analysis. Risks for which the probability cannot be estimated would normally use the as-low-as-reasonably-practicable approach. the ALARP concept contains legal interpretation of the regulatory process that promotes financial consideration …