Medical Device Software Validation

 The word validation is not new to today’s world but its requirement differs from field to field. In pharmaceutical industry and later in medical device field it almost become mandatory and based on risk assessment and class of the device its importance was seen as important both by regulators as well as manufacturers. In USA also the word MDR is popular in medical device. This is regarding medical device reporting guidance where in lot of guidelines with lot of reference of legislation is given. This makes every manufacturer whether doing business in USA or abroad but device is manufactured in USA. Similarly, the manufacturer is outside USA but sells product in USA are all governed by MDR. MDR is about medical device reporting. Why validation is important in MDR part? The Process Validation definition states that “ (a) Where the results of a process cannot be fully verified by subsequent inspection and test, the process shall be validated with a high degree of assurance and appr...

If you are in Medical Device field, CER is one of the important bases of your business and with progress of time lot of new requirement and addition to old compliance status have changed. With MDR coming in picture lot of new challenges have emerged to those who are in business of medical device since long but have not kept aligned with these developments and somehow trying to manage hard way to comply as they understand which can collapse anytime if any untoward things may happen. Writing and compiling of CER in many such manufacturers are done when device is ready for market. They just consider one of the legal document formalities like other documents needed. This is not the right approach. The scenario was completely different before 1993, when importance to clinical efficacy and safety was given as focus was on manufacturing and product quality. In 1993 came new EU directive and later with many amendments MEDDEV guidelines (latest MEDDEV 2.7/1 rev4, 2016) were released. This i...

 All Those involved in medical device field must be thorough with MDD (Medical device directive) and now familiar and knowledgeable with new regulation by EU MDR (Medical device regulations) Like MDR was made to replace MDD and then it was applicable to EU and UK, however situation changed for UK after BREXIT. We will restrict our blog to MDD Vs. MDR and what major changes are there which manufacturer or distributor must take care if they need to continue business in EU countries. (With Brexit even business with UK will also be possible if MDR is followed if certain aspects are taken care for administrative purpose)   Though one can say that MDR is not radically different from MDR but lot of changes have happened in MDD clauses and all manufacturers will have to do work for those as this is now effective after May 5, 2021. Though MDR has become effective, those who already have MDD can take advantage of various extensions extended and latest extension for certain device c...

 We learnt about what is 483, its consequences and if not taken seriously then it results into warning letter. We also learnt what is warning letter.   Let us now learn about what sort of 483’s are being issued in medical device industry in general by just looking at several types of 483s give to many in this medical device field. This will provide us the guidance as what are expected and how do we can avoid such 483 and make our inspection very worthy.   General trends in form 483 observations:   1.        Procedure not written or not fully followed. US FDA system suggests that any activity you are doing must be described in written form of instruction so all follow the same path and do not use multiple option. Since lot of documentation is needed it is observed that job is done in hurry to complete the requirement but that creates this deficiency. Sometimes it is written in such a way that it becomes difficult to follow or...

  FMEA is very important word in risk management. We all know that risk management is an integral part of QMS and regulatory compliance. As the name starts one must be thinking that this has something to do with failure in medical device. This is very incorrect, and this tool is to avoid potential failure. Origin of this is very old like in 1940 US military used this tool for looking at potential failure at design, production process, assembly of weapons and equipment. Let us just analyse FMEA. Failure mode: what can go wrong? Thinking and discussing potential failurelisting them down, Effect: What can be the impact of this failure if at all happens, what will be impacted, process, product or consumer, the analysis exercise of all in advance before we start is FMEA. Without going in the detail of when, what, where and how of this tool, know more about use of this tool in key element of medical device, design phase. Design phase is such an important phase where product is in form...