CE Marking and FDA Registration

1. CE marking & ISO 13485 certification What is CE Marking, ISO 13485, GMP certificate and How to get these certificates? What and Why you need CE Marking certification? CE marking has become mandatory for almost all the electronical and medical devices. Where this certification means to certify the product to assure health, safety and environmental protection among the living being like who is using it. By giving CE marking certification, the manufacturer would claim to assure that all its products meet all the essential requirements of all relevant European Medical Device Directives and make it ready to go out for markets and customers. How To Get This CE Marking Certification: The simplest ways to acquire this certificate are through identifying your EU requirements of the medical device or like so, testing with a Notified body Medical device of your product and then affix a declare conformity from the CE marking consultants. What and Why you need ISO 13485 certification? ISO 13485 certification as to be given to aid the medical device and its manufacturers for assuring quality management systems while designing the product and to establish and maintain the

2. effectiveness of their operation when it comes to usage. It also needed to ensure the consistent design, development, production, installation, and delivery of medical devices that are safe for their intended purpose. How To Acquire This ISO 13485 certificate simply: You can make the following steps with the help of ISO 13485 consultants. 1. Planning for Medical device that assuring Quality System 2. Implementing Design Controls when needed 3. Meeting all the Regulatory Requirements 4. Documenting, Recording and Training 5. Maintaining the Management Processes 6. Finally, start with The Certification Audition What and Why you need GMP Certificate? GMP Certification is simply referred to as the goods manufacturing practices and it has been mainly designed for the natural and pharmaceutical product manufactures as like for medical devices too. GMP is responsible for assuring the safety, efficiency, and quality of medical devices and other pharmaceutical products.

3. Our Consultants Specialized in offering: ● CE Marking ● ISO 13485 ● FDA 510(k) ● Cleanrooms ● GMP certificate ● Drug Master File ● US FDA Registration, and etc. How To Get This GMP Certificate: To get this GMP certification, all you need to do is to apply and complete the application process. The application for GMP certification has to be done by an authorized person within your company or manufacturing industry for seeking the certification and to submit all the things tey asking for testing. Then complete all the formalities and when your product meets all the specifications, they will issue the certificate. If you still feel confused about getting these certificates and feeling like a burden, don't worry we are here to make these processes so easy with Meddevicecorp for trusted and reputed CE marking consultants and more. Contact us today for more deals. Visit: http://www.meddevicecorp.com/ Call +44 2037594094 75 Executive Drive, Suite 303, Aurora, Illinos – 60504 FB: https://www.facebook.com/meddevicecorp Twitter: https://twitter.com/meddevicecemark Linkedin: https://www.linkedin.com/company/meddevicecorp/ Instagram: https://www.instagram.com/meddevicecemarking/