Steps for Getting CE Marking

 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 failure listing 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 formati...

  If you are in the medical device field, you must be aware of the word QMS (Quality Management system) for Medical Device. However, detailed knowledge with right interpretation of compliance requirement is must. Each clause needs to be understood with usual approach of what, where why and how. Each must be answered without any ifs and buts. ISO 13485 is universal international standard which describes all elements of QMS for medical device. This is followed in Europe, Canada and Australia and other countries except USA. USA follows its own standard 21CFR part 820. Though Brazil and Japan have their own standard but those are based on ISO 13485 and FDA QSR.  ISO 13485 is standard for QMS documentation for medical devices Apart from this Europe also had MEDDev regulation which is now got replaced with MDR which also describes certain special requirements. This regulation is also must for compliance if you want to enter European market. or USA 21 CFR part 620 compliance is mus...

  USFDA uses the structured way of communicating to Pharmaceutical or medical device field entities to communicate their observation during audit. In Medical device field if firm deals in Class II or Class III categories then USFDA inspection is expected every two years. Inspector conveys his finding of non-compliance observation in the defined form called form 483 . The observations are listed in order of most significant to less in that order. The investigator issues this along with EIR-Establishment investigation report. This is also discussed during closing meeting and firm can ask question, understand well observation, and try to resolve them if they find less significant and minor and some time show some evidence of action or completion of action before inspector leaves. The form 483 and EIR both are also studied at district level and higher level. If the district office or higher-level office find the one or more listed 483 observation as serious enough, a warning lette...

  As we all know that some of the   USFDA regulations   are extremely specific and special for medical devices and IVD which are supposed to be sold in USA. So even for Global manufacturer, approval in many countries and selling them would not just automatically gives approval for sale in USA. Recommending  USFDA consulting to medical device  and IVD manufacturer may look sales gimmick so let us first look what are the requirement and corresponding regulation or documentation. 510K submission, IDE (i n vestigation device exemption) submission or clinical trials, for Classification query and resolution, if manufacturer is outside then effective representation, Audits and audits of suppliers, form 483 and warning letter resolution, apart from other general guidance on day-to-day affairs like pre submission meeting, 21 CFR part 820 understanding. There are enough guidelines and documentations are available like some specific cases of IVD classification, justificati...