Medical Device Quality Management System
All You Need To Know About Medical Device Quality Management System
The QMS (Medical Device Quality Management System)
It deals with all the details of the medical device in a structured method such as manufacturing, design, etc. The companies manufacture the devices of medium-risk and high-risk need separate QMS execution than the companies making low-risk, non-sterile, non-measuring, non-reusable surgical devices. Thus the Medical Device Quality Management System varies according to the device product. We provide the required guidance to follow all the regulations to the manufactures of the medical devices.
Regulations To Be Undertaken For A Medical Device QMS
This regulation is mandatory for all the companies as a rule for the registration of the product. The Device manufacturers in Europe and in the US follow different regulations as per their national standards. The QSR is followed in the US with its regulations for the companies of medical device manufacturers. If the US companies supply their products in the international market, they need to follow both these systems to manage the supplying process.
The Connection In Between The Medical Device Approval And Your QMS
The US FDA needs to follow with the 21 CFR Part 820 during the registration of your product with the FDA. All the companies that manufacture medium-risk devices need to follow the 510(k) method. When this is submitted by you, it is required to be following 21 CFR Part 820. The application of the US FDA is undertaken by general inspections. These may happen at any time for the manufacturers of the medical devices. Hence, it is mandatory to be ready with the fulfillment of all regulations.
It is different in Europe as you need to get the CE Marking for all the devices as a rule for the distribution. The usual procedure for the companies to follow the needs of Article 10 and the Annex IX is by the certification of the third-party for the ISA 13483. This is done by the auditing organizations termed as Notified Bodies (NBs). The important thing to be noted is that there are other means to undergo European QMS needs. This includes the requirements listed in Annexes X (conformity assessment based on the product testing) and XI (Conformity assessment based on product conformity verification).
Ultimately, the Health Canada (the Ministry of Health) needs confirmation to ISO 13485:2016 by the MDSAP certification since January 1, 2019. This means the companies that plan to sell in Canada required to follow the QMS complaint along with the ISO 13485:2016. If you have plans to sell in Canada, you will need to implement a QMS compliant with ISO 13485:2016!