Medical Device Software Validation

Every businesses workhas   complex compliance requirements, from anti-money laundering laws to consumer protection, labelling safety and environment protection.Similarly, there is very highly regulated pharmaceutical industry and medical device business must comply not only local laws but also of the countries where they are exporting. This compliance is not just on product quality claim by manufacturer but must meet all requirement like manufacturing its environment, testing, various other actual testing on human called clinical trial where needed. Business must comply with all compliance requirement otherwise consequences are severe like not just financial loss, business closure but also punishment of imprisonment to certain direct people. Let us talk about Medical device business compliances. They are majorly divided into two areas where manufacturing compliance requirement is there and other is directly dealing with regulatory authorities’ time to time basis for ever cha...

First and foremost, question must have to mind that why MDD was to be re-written in the form of MDR. Regulation keep changing through periodic updating, but this is major change where many changes were incorporated in new document called Medical device regulation (MDR) The European (MDR) is going to be a new set of regulations that governs the assembly and distribution of medical devices in Europe, and compliance with the regulation is mandatory for medical device companies that want to sell their products within the European marketplace . 1.           Why did the MDD need an update? With the progress of IT industry, more and more software started coming and its use in medical device also started. This came into form of an application or governing medical devices where patient can also see his/her own monitoring. During old days when MDD was written this did not exist. So, need to regulate such development, MDR was born. There is a growing push for transparen...

  If you are medical device manufacturer and you are now you think you are ready with medical device and wants to launch in the Market. Some time you may not have regulatory back up to do job on your own and you may think of hiring consultant. No Issues, this is what most companies do. Steps to follow to bring to market are same for long period of time like normal documented process from design to release in the market. You may feel easier job, but do you know that regulation you have read and tried to comply successfully has changed now? These are happening every now and then based on feedback of users and medical device professionals. Regulatory bodies like US FDA and EU MDR act and change regulation in the interest of patients who are real impacted people. This is where role of consultant competency counts. Choose consultant but do ask them following question before hiring. 1. HAVE YOU HELPED A COMPANY PASS OUR REGULATORY STANDARDS? If yes, which one US FDA, EU MDR? 2....