CERTIFICATIONS
At Modern Orthodontics, we believe in delivering rather than promising. This is why we offer products that are certified to the best global standards as proof of our commitment to quality. Our wide range of region wise and systemic certifications stand testimony to our policy of delivering quality in everything we do.
CE Mark for European Union
The official marking mandated by the European Community is the CE mark. CE Marking is the "passport" that enables producers from any country to sell their products across the entire European market. Our CE certificate as per EU MDR regulations has been issued by SGS Belgium NV
US FDA Registration
The US FDA approves the quality and claims of any product directly consumed by people to protect and promote public health. Since orthodontic products fall under the purview of US FDA standards, we manufacture our products in compliance with these standards. We are registered with the US FDA as a manufacturer
Quality System Management ISO:13485
As the golden QMS standard, ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. Our ISO:13485 certificate has been certified by UL LLC.
MDSAP Certificate
Medical Device Single Audit Program (MDSAP) is a program that allows the conduct of a single regulatory audit of a medical device manufacturer's quality management system that satisfies the requirements of multiple regulatory jurisdictions. Participating countries in the MDSAP are Australia, Canada, USA, Brazil and Japan. Our MDSAP certificate has been issued by UL LLC.
India CDSCO Manufacturing License
As the latest Indian Medical Device Rules, CDSCO mandates all manufacturers and importers of medical devices to be fully licensed in order to safeguard the public health and bring regulation to the medical device industry. We are a fully compliant manufacturer of orthodontic products in India licensed by the Govt. of India.
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