Purpose of ISO 13485 certification: Medical devices
In the medical industry, this ISO 13485 certification is made to be the International Standard under the Quality Management System (QMS). The ISO 13485 is considered to be the basis for the QMS for all those medical device manufacturers. Global quality services work with the aim of bringing the best consultation services for the medical device manufacturers in the process of achieving the higher end ISO certifications, so that the people can use the medical devices with utmost quality and perfection. If you are the supplier or the medical device manufacturer, this ISO 13485 will serve as the good choice and it contains some chapters regarding the servicing of products and some regarding the projections of it.
If somebody is looking for a quality product or service, the medical device manufacturer will look into the supplier that they hold the ISO certifications and then they ensure about the quality of the product. It is also important to understand that the EU (European Commission) is recognizing the ISO 13485 nowadays. This gives us the sense that the European Commission has provided harmonized standards regarding the ISO certification to the medical device manufacturers. These standards will contain a list of quality principles that achieves the best quality medical device. The reference for such an EU standard is given as: EN ISO 13485:2016: Medical Devices – Quality Management System – Requirements for regulatory purposes (ISO 13485:2016), EN ISO 13485:2016/AC: 2018.
The harmonized standards for ensuring the quality of the medical devices includes some of the directories as MDD 93/42/EC, AIMDD 90/385/EEC, and IVDD 98/79/EC. This is also helpful to find out the flaws or errors in the product or the services and if any inhibitions happen then they are subjected to the compliance under the regulatory standards. If you are a medical device manufacturer or a medical device company and if you are producing quality products to the market then this ISO 13485 certification is the best choice for you to make all your quality products to be certified.
Getting the ISO 13485 certification:
For any medical device manufacturer, it is necessary that the ISO 13485 certification must be available for all their products to ensure the quality. Global quality services, which serves as the leading consulting firm for offering the ISO certification to medical device manufacturers or the medical device company and we focus on delivering the leading services for the same. The process to get the ISO 13485 certification starts with the process of getting the ISO standards that are available at the ISO.org platform. Under the standards, you’ll be finding a lot of managements and you can look into the guide for the further process. After this, you need to contact the proper ISO certification body, who’ll help you in the process. The certification body will perform all the audits at your place and then the verification process by the certification body will be done. You need to fulfill all the requirements of the ISO 13485 certification, and that’s the case where you will be certified by the body.
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