Medical Device Regulatory Consulting
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, …
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Chapter V section 2 of conformity assessment procedure based on Article 52 Conformity assessment route for class I device as per Article 52 of clause 7: Class I Annex II and III of Technical Documentation Class Is/Im/Ir Annex II and III of Technical Documentation and Annex IX QMS Chapters I, III Or Annex II and …
Biological Evaluation is a series of tests performed pre-clinically either through invitro or in-vivo techniques to assess the biological safety of the device. When the medical device comes in contact with the body, it should be assessed for its safety upon use. The biological evaluation shall be planned, carried out and documented by knowledgeable and …
The Risk-Benefit analysis has to be performed, when the residual risk is not judged as acceptable using the criteria established in the risk management plan, and further risk control is not practicable, then the manufacturer may gather and review data and literature to determine if the medical benefits of the intended use of the medical …
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 …
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Rule 1 to 4- Non-Invasive Devices Part 1 Classification rules have been changed for some devices in MDR. Devices shall be divided into classes I, IIa, IIb and III, by the intended purpose of the devices and their associated risks. Here I am explaining the major changes in the rules of MDR when compared to …
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The UDI (Unique Device Identification) is a series of numeric or alphanumeric characters that is created through a globally accepted device identification and coding standard. The affixing of the UDI is an additional requirement for labels or on the device itself, it does not replace any other marking or labelling requirements. Only the manufacturer may …
MDR defines Risk as the combination of the probability of occurrence of harm and the severity of that harm. A Risk Benefit Analysis helps to balance the benefit with the inherent Risk. As per article 10 of MDR, Manufacturers shall establish, document, implement and maintain a system for risk management as described in Section 3 …
A medical device label helps to identify the individual device and to communicate with the user about the safety and effectiveness of the device. Where appropriate the labelling should use symbols and its additional explanation text should be include in information supplied by manufacturer complies with harmonised standard EN ISO 15223-1: 2012 . Apart from …
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Medical Device CE Marking 