Prerequisites For A Medical Device Quality System

A handsome amount of money needs to be invested in the development of a medical device quality system. However, the most common problem which most startups face is the lack of financial backing from the investors. Thus, the importance of a having a good quality system gets faded behind things which need immediate action and are considered to add more revenue to the company. The idea of the development of such a device system gets completely ignored till the product gets launched by the company. To make the development of medical device quality system mandatory, many countries have issued many rules and regulations which have made it mandatory for the developer to have a good quality system if they want to do business outside the country.

A careful analysis of the quality system requirements would show that most of them are related to the production phase. The phases which pertain to the development of the product are discussed below.

• Design Control: A foolproof design control procedure proves to be the foundation stone of having a sound medical device quality system. This phase is considered to be the most important part of the development phase. During this phase, the key features are noted down to prove that it meets the demands of the people and is safe and secure to be used.

• Risk Management: Having a procedure to control the risks associated with the design is the second most important thing in the development phase. The primary task at hand is to identify the risks associated with the intended use of the device and devise a solution to those problems. Also, the severity of the risks should also be noted to take a decision whether the design is proper or not. All these should be documented for future use.

• Document Control and Records Management: Proper documentation is a very important aspect of all the phases during the development cycle. Thus, there should be a proper system to maintain these records and documentations for future use. These documents stay with the company till its existence. So, even the minute details about the revisions and approvals of the reports and documents should be maintained with proper care.

• Supplier Management: A proper list of suppliers should also be maintained in order to ensure which raw material is being procured from which vendor. The most important thing to remember here are that the suppliers must be well-qualified which can be judged based on the quality of raw materials supplied by them.