A handsome amount of money needs to be invested in the development of a medical device quality system. However, Prerequisites 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 fad behind things which ne immiate action and are consider to add more revenue to the company. The idea of the development of such a device system gets completely ignor till the product gets launch by the company. To make the development of mical device quality system mandatory, many countries have issu 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 relat to the production phase. The phases which pertain to the development of the product are discuss below.
Prerequisites Design Control:
A foolproof design control procedure proves to be the foundation stone of having a sound medical device quality system. This phase is consider to the most important part of the development phase. During this phase, the key features note down to prove that it meets the demands of the people and is safe and secure to use.
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 note to take a decision whether the design is proper or not. All these should be documented for future use.
Document Control and Records Prerequisites 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 maintain with proper care.
A proper list of suppliers should also maintain in order to ensure which raw material is procuring from which vendor. The most important thing to remember. Here are that the suppliers must well-qualified which can judge based on the quality of raw materials supplied by them.
Thus, putting some amount of effort in these major areas would help you develop an efficient medical device quality system.
This Act of Parliament brings into law an offence of Corporate Manslaughter where a Company. Partnership or Owner can found guilty of causing death by gross negligence. Previously it was necessary to prove that someone within a Company, Partnership or Owner was guilty of gross negligence.
Prerequisites Far from bringing:
Relief to Company Director, Managing Partners and Owners. This could a double edge sword as the organisation can prosecuted as well as the Senior individual.
Here is part of the Act which gives guidelines for Jurors to consider. When trying a case brought under the Corporate Manslaughter Act