Let me start with the basics! In simple words, a medical device quality management system (QMS) is an organized system of procedure and processes. This structured system covers all aspects of design, manufacture, supply management, risk management, compliance handling, storage and distribution of clinical data, product labelling and many more.
Almost all medical devices require some form of QMS. The complexity of the QMS depends upon the medical device classification. For examples, medium risk (Class II) and high-risk devices (Class III) requires different QMS implementation than low risk, non-sterilized, no-useable, non-measurable instrument devices that fall under Class I.
Many companies offer medical device contract manufacturing service to help the medical industry mitigate risks and meet legal compliance.
Challenges Medical Device Manufacturers Face
The medical industry is exciting yet highly regulated at the same time. The regulation need is obvious because a medical device that malfunctions have a greater impact than a cabinet door that does not shut properly!
Therefore, a medical device that is manufactured and sold must have FDA approval. Moreover, a medical device should meet ISO standards for credibility and is mandatory in many global markets.
How Quality Management System gives medical device companies a competitive Edge
The winner in the medical device industry is the one who gets to the market first with a quality product that works – and keeps on working. And this is only possible with a quality management system. Here are the prime benefits that a QMS offers:
1. It helps to keep your medical device design FDA Complaint
Why the FDA compliance matters? The answer is that it a legal duty! The FDA has a set of requirements that necessitate the medical device product development process. If any manufacturer fails to meet these requirements, the consequences can be facing jail, heavy fines, or a severe injury or death of a patient.
A QMS can help to meet the FDA’s requirements and provides a shield against legal prosecutions.