Heading - Have you asked these questions to QMS Software Vendors in medical devices?
As a medical device company,you are expected to deliversafe, long lasting, which will make patient feel pleasant change in his life. For the progress of your company an innovation is must. While doing all these you must remember that you are governed by quality management system and regulatory compliance of your region.This task bears numerous responsibility - all that should be unbroken and documented inside your quality management system. 1. Is that the QMS is specifically made for medical device companies? Short answer is no but QMS is applicable in many manufacturing industries and service-oriented industry also. QMS for medical device calls for special attention as it deals with human and negligence in this area can cost you heavily. Many solutions are available with user friendly tools but there can be hidden cost involved in implementing the same which may not appear on the face price of that solution 2. Does the QMS software you are considering, align with all major class of medical devices requirements? Does it also cover regulatory requirements of India as well as Europe (EU MDR) and US FDA (USA regulation)? Please remember that regulations for Quality Management system, on face value appear same but executional requirements differ with countries of Europe which follow EU MDR and USA which follows CFR for medical devices.If you falter in following any above rule can result into recall of your medical device already sold in the market and if damage to patient is involved, then heavy compensatory claim needs to be settled. 3. Is the QMS software you are considering is user friendly and simple enough to implement quickly, however powerful enough to meet all requirements required for all class of medical devices and also have a scope to cover future growth? Complicated QMS software can cause hurdles in implementation and difficult to follow. All employee may not be able to grasp it and can cause frequent non compliances in implementing. As stated above QMS and regulatory requirements are back bone of any medical device. Weak software lays weak foundation and so the future of company. This also affects the very basic quality of the Medical device. When looking for a QMS software solution, it's straightforwardfind answer to above questions and also ensure that you get all required functionalities to cover present requirement of your organisation and also take care of future goals. Let us be honest - no company desires to speculate a lot of cash outflow during a strong QMS code resolution that becomes too overwhelming to figure out from the beginning.