Medical Device Software Validation

  Whenever any new device is designed or design is revised, designer’s first focus usually goes towards its functionality and performance and is very conscious about this. Consider very high fashioned shoes which looks very attractive but fails if it hurts while wearing. Though user requirement is one of the important requirements some time it is ignored unknowingly. Presently during covid epidemic lot of masks came into market but discomfort while wearing on ears was not prime criteria even for users while buying though it was supposed to be worn for long time. With development of knowledge and experience of field event post marketing surveillance data design approach has changed. Keeping human factor in mind has now become best practices. That is why design engineer focuses on users who consider product as not only efficient but very user friendly while using. Its also a challenge as The medical device industry is vast, and products are often intended to be used by many vario...

  In medical device industry risk assessment has played very important role and it is not a matter of choice but also a regulatory requirement and proper methodology and documentation is necessary in support of justification. Risk assessment with severity and probability is well defined and has been used by industry since the concept came into practice and risk ranking of critical, major, medium and minor are being assigned and used as regular practice. For medical device to be approved, risk mitigation factor and its use is very important for each device. This must be defined well. Described and justified well and in critical risk cases it must be proven through validation. One of the most common risk mitigation measure is on data entry. In pharmaceutical world there are various operations where people have to make data entry (including batch records). This is one of the most common area of risk. So as mitigation measure most of the places all critical data entry or critica...

  In the medical device industry, it is regulatory requirement that information accompanying device must be in the language that is possible to be understood by user and or care giver usually doctor. So, translating is not a choice. It is essential that translation is not just colloquial language and slight variation is also an issue, Medical terminology must be unique and specific to that region or country. Since this being very important subject and compliance is on high agenda, most industry prefer professional translator who are recognised by regional or central government agencies. Some factors contributing to the challenging task of medical device translation are: If we understand the complexities of translation, then only real work result will come. Translation here does not just mean verbatim translation. Look at following essential points. ·          Medical terminology / lexical and colloquial differences between languages...