Steps for Getting CE Marking

Before we go into clinical trials and its criteria, let us first understand what clinical trial is. The word trial brings many questions in mind. Trial means experiment? Is it safe? Do one should participate? Why is this allowed? Who controls this? It is well known in its definition that it is r e search study in which people participate where some patients suffering from some ailments and present available medicine does not help while new medicine under development is promising. This patient can volunteer for such trial as it may turn out beneficial for patient. As we all know such trials are governed by regulatory bodies.  USFDA   is considered such reputed regulator which is recognised in almost whole globe. USFDA itself never conducts any trial but as regulator it has set several criteria for conducting those trials. Let us look at those criteria to understand more about those trials. It is conducted through protocol, which is written and approved plan for executing, docum...

  The word configuration comes into mind we immediately think of few orderly items associated with one main item. When we talk of configuration management for any product say medical device then, it is the process approach of establishing product’s performance, functional and physical attributes, with its requirements which is best gained through its design and operational information till lifetime of product. In case of medical device compliance level must be excellent.  Configuration management  helps maintaining and creating, required attributes, functional characteristic and specification not only for the product but also for manufacturing process. Configu r ation you offer must be very user friendly. It allows user to select what user needs but it should not confuse users means that user selection should worry for interdependency of selection and what is opted out. Clarification at the selection stage make user understands what is being selected and whether it will m...

  Merger and Acquisition   is now commonly heard news every day. This started with many multinational companies. Sometimes it is merger of two big companies with emergence of new company or sometime a big company acquires business of some other company which is Acquisition. Objective is mostly strengthening business but w h en merger and acquisition happens it is not just business is acquired but all systems and whole part of that unit is acquired. Most of the time this is not the choice hence integration of all departments like HR, Marketing and sales, Procurement, are also acquired along with production, QA, RA and development. In this blog we will restrict the acquisition of medical device business where merger and acquisition shall need focus on compliance part too. Just imagine company acquires business of the company who were selling product with compliance issues causing complaint and couple of recall. This type of issues not only harm the business but also have impact ...

  Let us take case of one medical device Industry with quality system established with ISO 13485,   EU MDR   and   US FDA   relevant requirement. Products are registered with CE mark for Export to Europe. The firm is US FDA approved and doing business in USA with substantial financial stake. Being US FDA firm, it must undergo US FDA inspection at regular interval. This is decided by US FDA as when to inspect and what scope they will cover. The firm undergoes one  s uch inspection and Inspector finds some compliance issue points during inspection. These issues need to be resolved to US FDA satisfaction failing to do that satisfactorily generates FDA 483, Warning letter. FDA remediation thus is nothing but to address the compliance issue raised. Very important aspect of resolving these issues is to first understand all problems, make effective CAPA plan, (it is assumed that CAPA plan already takes care of issue that such problems will not repeat in future), E...