Certified Quality System

Our Quality System is ISO 13488 certified by TUV Product Services and meets current FDA Quality System Requirements.  Not only are we audited by the FDA  and TUV, we are also audited by each of our clients.  We maintain complete traceability and device history records for every lot that we process and we provide written certification with every shipment.

Need ISO/EN certification? Traditionally, medical device companies have had two choices: Hire outside or temporary personnel. Have them write volumes of documentation, which may or may not be appropriate to the actual operation of your company. You may end up with a system that is so burdensome, it could actually harm your business operationally and financially. Struggle with the process internally. It can take a year or more to complete. It will tie up critical personnel who will be delegated the task of writing detailed work instructions for activities like "Returned Goods Authorization" or "Facility Cleaning and General Housekeeping". Shouldn't these people be developing your products and business? Either process eats up valuable time and resources, which could be better invested in revenue generating activities. The MDM way... As a medical device manufacturing company, we have developed a Quality System that meets both FDA and ISO/EN requirements. We wrote the entire system with one purpose in mind, "To provide a complete system, which fits the requirements of startup, small and medium sized medical device companies." In fact, the system we are offering is the very same system that MDM utilizes every day, and which is certified by TUV Product Services. We provide Tier I, Tier II, and Tier III documentation for all sections of ISO/EN. We've done the majority of the work. You simply customize the documents to fit your specific needs. You spend a fraction of the time and effort necessary to create a system from scratch. Need to achieve certification quickly? Now you have a cost-effective option!