FAQ

Rhein Laser embraces the purest and simplest concept of beauty rooted in authenticity. We integrate this concept into daily life by offering a comprehensive range of medical aesthetics and pain management devices at cost-effective prices.

Rhein Laser is an international brand that employs talents around the world, ideas and technologies from the United States and Europe, and integrates the culture and market knowledge of China and other Asian countries in the form of overseas return.

ISO 13485 is a quality management system established for the medical device industry. It helps medical device manufacturers establish standardized processes within the factory. ISO 13485 is an independent standard that includes the various standards of ISO 9001, plus other industry-specific medical device requirements.

Not only do TFDA and the US FDA require medical device production lines to have management systems similar to ISO 13485, but in the EU Medical Devices CE Mark Certification (MDR (EU) 2017/745 CE), although obtaining ISO 13485 certification is not a necessary condition for obtaining the CE mark for medical devices under the EU Medical Devices Directive, it is still recognized as a unified standard in the EU. Therefore, if ISO 13485 is met, it is presumed to have met the basic quality assurance requirements of the EU CE mark (but other EU regulations should still apply)

Medical device manufacturers must establish relevant quality management systems based on the regulatory requirements of the national health authorities where the products are expected to be marketed. For example: Taiwan → QMS/QSD; US FDA → QSR; Single Audit Program (MDSAP)... etc.

All of the above regulatory requirements are based on ISO 13485, but medical device manufacturers are qualified to manufacture in that country only after they have been audited and approved by the health authorities of each country or a third-party certification unit.