Medical Device Software Validation

 MDD (Medical device directive) which was regulation for medical devices then in some EU countries is now getting replaced with new regulation called MDR (Medical Device Regulation) MDR is designed to be an improved version and one of the important facts is that it influences and effective in all 27 member EU states including UK . Legal base of regulation will shift to EU and not like MDD where individual country was involved. One of the important steps is that even current companies with their products already in the market are also going to be influenced by new regulation and they must ensure their existing product comply to MDR. This will help overall improvement in the field of medical device. Making some empirical comparison; MDR is four times bigger document than MDD . The word safety appears 290 times as compared to 40 times in MDD. This itself explains the impact. Nothing is removed from MDD but lots of additions have been made in MDR. All additions are new to improve saf...

 Without going into definition of compliance as it is clear precise word but has lot of implications on your product and business. Compliance is not a choice, but it is must. It is not debatable. Though guidelines are available it becomes difficult to interpret sometime leading to wrong path. Taking compliance lightly may lead to product safety issues thus heavy price to business. In Medical device field like any other pharmaceutical, cosmetic product field, regulators has laid down certain rules and conditions for product safety and for the benefit of consumers who uses these products. Once you are compliant to say, US FDA requirement, it automatically means that products are safe to use, thus it gives sort of certification to consumers. Having said this, why it is necessary to have US FDA consultant ? Regulatory requirements are everchanging phenomenon and it is difficult to keep chasing the same and understanding the compliance need for each requirement. That is where these ...

  What is An FDA Form 483?   A Form 483 is a form through which FDA inspector reports and communicates the results of his audit findings to a head of facility. This is a regulatory form and all findings are bound to auditee and they need to be closed through corrective and preventive action.The observations are usually mentioned in descending order of importance. Some time they are referred with picture of spot or shown to a witness touring with auditor or document is attached to site some observation or noncompliance. Organisation needs to understand before auditor leaves. ·          Gain an understanding of observations noted and assure their accuracy ·          Understand the broader message the agency is sending ·          Identify and discuss any errors in observations ·          Ask questions · ...