Medical Device Software Validation

 Alcohol does not need explanation but drug needs clarification in our subject what we are talking of drugs are nothing but prohibitive drugs used for so called mental enjoyment which is nothing but abuse. These people if drive on the road can be dangerous to other people and they can injure or kill others on road under the influence of alcohol or drugs. There are some other prescribed Drunk (Alcohol influence) driving or driving under influence (DUI) of drug is a criminal offence in India and several countries. There are various other terms like DUI. Driving while intoxicated (DWI), Operating while intoxicated (OWI). There are age limit for drunk driving between 18-25 years by different states but even alcohol limits are prescribed in blood (30 mg per 100 ml) anything beyond is treated as DUI case. Some states have totally banned alcohol while driving. The same also applies to drug so any person under influence of drug to such an extent that he/she is incapable of exercising a...

This is especially important subject in medical device world. Understand strategic transition, one needs to go in detail as what is MDD with respect to MDR, why transition? And what transition? MDD was labelled as directive, has quite relevant content but was not sufficient in view of rapidly changing technology which could deliver much advanced medical devices but also could have risk if it were regulated just by MDD. Objective of new MDR in broad category was to bring, improved consistency, better traceability, and transparency in regulatory process. Post market performance became particularly important aspect to judge newly designed advanced medical devices with modern technology. It is especially important to note that MDR is regulation as ‘R’ of MDR stands for regulation and it is must to adopt. New deadline for MDR compliance was 26 th May 2021. Now it is on and all those who are doing business of medical device in Europe has to see its compliance or else there will be huge i...

 Validation has become very common word for those who are associated with pharmaceutical industry and now it has been adopted under main quality system and become one of the regulatory requirements. There are several challenges in pharmaceutical processes, validation is one of that. This is merely due to its scope and complexity. Mere testing of product, even doing several timesand in detail does not provide assurance batch after batch and variations are likely. To ensure the variation within narrow range, control on the process is very essential and to know what to control also sometime emerges from process validation data. So let us start with official definition of process validation by FDA, “the collection and evaluation of data, from the process design stage through commercial production, which establishes scientific evidence that a process is capable of consistently delivering quality product” Thethree-line definition states a lot because it starts from process design ...

 Those who are in pharmaceutical industry as well as medical device industry are familiar with term “form 483”. One this is mentioned one understands that the industry deals in products manufactured in USA or exported to USA. Why is it called 483? When FDA investigator does an audit of any facility under their purview and records the observation in one defined form which was designated as form 483 by US FDA in their internal documented system. It is like unit gives various formats numbers to be used in their documented system as per its quality system. It contains Header information , (FDA district office information, date of inspection, name and address of facility, Name and title of person to whom this form is given, brief description of the facility including facilities FEI (Facility establishment identification) number. Observation including annotations . This section is heart of the form for which this is made and may run into several pages. It starts with disclaimer ...