Steps for Getting CE Marking

    “When do I need a Quality Management System (QMS)?” is the most common question that we get from new clients who are just entering into the medical device field. The answer depends on your target market and your exit plan. QMS is quality management system as the name suggests this is an essential for any simplest medical device too. There are two aspects of QMS. One initial is to build system wherein you will document system mostly as per ISO standard 13485. System build means, write down the procedure for each section of ISO stating that what, how, when and where you are going to do. At this stage you are only developing strategy or system but not doing anything in action. In second stage you will carry out action and create evidence of action through records of your system. This is an explanation for QMS one must do. This is just basic need. Then comes regulatory requirements which are different for different countries. These are must requirement, and you have no choice ...

  Why this question arises? Medical device recalls, which are highly undesirable are not stopping are on rise. The devices which are coupled with software are amongst them and poses new challenges. Over a period with new development in IT, software use has become so much and inevitable, that one cannot say let us stop using them. The alternate way is to make it more control l ed and regulated. Software use has become so much that in some medical device it is playing very important role which is so detrimental that it also needs to control so regulator has made that software itself as medical device, so it automatically get governed by all applicable regulations. IEC 62304  standard came into existence due to above facts only. The standard is designed to provide lifecycle approach to govern software. Life cycle approach with activities and tasks to govern safe software design and maintenance of the same. Each life cycle process is further divided into many sets of activities an...

  Any regulatory system always insists for written instruction for how to carry out any processes and needs written verifiable data in written form. This does not mean that it must be in hard copy mode. Digital mode is also acceptable provided it satisfy control, safety, and integrity requirements. One of the biggest advantages of written documentation is that everyone follows the same system and shares the data universally which can be utilised for betterment of patients and users like medical professionals and others. What is needed in   QMS for medical device ? Detailed list will be very long but let us try to cover essentials of what is described in ISO, US FDA, EU regulatory guidelines. Scope of this blog is that what area are essential to cover and very very essential to cover in that area. Let s take some references which will be essential to refer for this.  ISO 13485 –2016,  US FDA 510k submission  guideline,  EU MDR guideline  replacing old M...

  The word validation is so important that its misinterpretation can lead us to non-compliance. Its of f icial regulatory word. Let us understand in layman’s language. We have process to produce piece of material with length of 50cm and specification says 50 plus and minus 1 cm. This means any piece above 51 cm and any piece below 49 cm will not be accepted. So, what is issue here measure all pieces and select the only one in range. Looks very easy but if you are producing 5000 pieces per hour and you are running machine for 12 hours continuously. Can you check all 60000 pieces? Process excellence came into practice and stated whether your process is capable to produce product with desired specification? Say for one time you will measure all 60000 pieces and you find them all between 49.5 to 50.5 CM. This is great so now you occasionally check at regular interval, and you still found within above range, one can prove that process is capable and stands validated. The Medical device ...