Steps for Getting CE Marking

  Form 483 and warning letters are worry some or warning words for all those who are in Pharmaceutical and Medical device field. Those who deal with US FDA and doing business of Pharmaceuticals and Medical device in USA are most concerned when these two things appear. Even senior management gets concerned. Senior management may not get worried about some major observation in the internal audit which may be worth warning latter but gets worried for 483. Getting 483 is not so uncommon but passing the investigational audit without 483 becomes more prestigious than some other more important event of organisation.   As we all know that 483 is issued at the end of investigational observation by investigator which is officially also called “Notice of inspectional Observation”. This observation is quality system deficiency observed by Investigator.   Investigator also presents this 483 to his seniors. If the reply prepared for this 483 describing your approach for addr...

Most of those manufacturers of medical device having customer base outside India and specifically if in USA, must know about FDA regulations and ever-changing additions and deletions to that. If some thing is not taken care due to lack of knowledge, late knowledge, or appropriate knowledge, it becomes very expensive affair for the firm including closure of business, depending on the criticality of the issue. Bigger firms having wide business in USA and Europe normally employ experienced and expert regulatory person on their role to take care of regulatory affairs on day-to-day basis and to resolve issues when they arise. However, it is still sometime some complex issue emerge due to 483 or warning letters or some regulation change and its impact on medical devices which are already in the market, may be very high. In such situation firm’s inhouse resource, may not be so useful and some outside consultancy may be required. How do we select US FDA consulting firms which can be usef...

  The word Validation is most used in Pharmaceutical and Medical Device industry. It is such an important requirement that if not done, or not properly done, invite warning letter from US FDA while various punitive measure may emerge from other regulatory bodies involved in Pharmaceutical and medical device Industry. Most of the warning letters are issued by US FDA is on validation aspect and it also becomes difficult to manage. Validation is operational activity where various process activities are done and data evaluated while regulatory people who are direct link with regulatory body knows the importance of validation but do no know much about this. Operational people though perform the validation but rarely challenged about the process followed and later gets challenged by regulatory bodies. It is thus particularly important to know what validation is. There are several definitions so rather than going through definition of CFR 21,820 which is broad, let us understand the ...

  These terms used for medical devices are sometime misunderstood and used one for another, but both are distinctly different. Though clinical investigation data is often used in Clinical evaluation report , clinical investigation is one of the requirements of MDR like clinical evaluation. Let us further examine to understand the difference better.   Though detailed discussion of clinical evaluation is not the subject of blog, it will be essential to briefly describe the process of Clinical Evaluation so that difference can be understood better. Let us go to the brief definition of Clinical Evaluation Report (CER). Clinical evaluation of medical device is a continuous process of generating, collecting, analyzing, and evaluating clinical data under assessment to demonstrate conformance with general safety and performance requirements as per the manufacture’s intended use. This process starts with development stage and continues through life cycle of device.   Clinica...