1 / 4

Medical device FDA 510k Clearance, Submission and Premarket Approval

Operon Strategist is a leading medical device consultant providing FDA 510k Clearance process consulting to the customers to register SBU( Small Business Unit), if applicable. Take out the testing demand of the product, creation of the dossier, resolving the queries and after completion of all the conditioning, the customer receives the US FDA 510 k premarket approval. We also help with the establishment enrollment and device listings to make suitable the supply of medical devices in the US.

operon1
Download Presentation

Medical device FDA 510k Clearance, Submission and Premarket Approval

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. Title - FDA 510K Consultant Medical device FDA 510k Clearance, Submission and Premarket Approval

  2. What Does a FDA 510( k) Clearance mean? Medical devices for human use within the United States must be submitted to the FDA to determine if the product is safe and effective. To do this, in utmost cases a company must compare their product to one formerly cleared by the FDA and give substantiation that their product is “ substantially equivalent ” to the preliminarily cleared( legally marketed) device. To be mainly original, the product must meet criteria for the same intended use, have the same technology or( slightly) different technology but produces similar end results, and be safe and effective.1 Once “pre- market clearance ” is took from the FDA the device can be distributed commercially immediately. There are important differences between “ cleared ” and “ approved ”. When a medical device is cleared, this means it has experienced a 510( k) submission, which FDA has reviewed and handed clearance. For Class III medical devices to be legally marketed they must suffer a rigorous review and approval process orpre-market approval( PMA).

  3. OPERON STRATEGIST IS A LEADING MEDICAL DEVICE CONSULTANT PROVIDING FDA 510K CLEARANCE PROCESS CONSULTING TO THE CUSTOMERS TO REGISTER SBU( SMALL BUSINESS UNIT), IF APPLICABLE. TAKE OUT THE TESTING DEMAND OF THE PRODUCT, CREATION OF THE DOSSIER, RESOLVING THE QUERIES AND AFTER COMPLETION OF ALL THE CONDITIONING, THE CUSTOMER RECEIVES THE US FDA 510 K PREMARKET APPROVAL. WE ALSO HELP WITH THE ESTABLISHMENT ENROLLMENT AND DEVICE LISTINGS TO MAKE SUITABLE THE SUPPLY OF MEDICAL DEVICES IN THE US. WE HELPS DURING THE PROCESS OF SUBMITTING OPERATIONS FOR CLASS I, II, III MEDICAL DEVICES AT ANY STAGES OF THE PRODUCT DEVELOPMENT. OUR TEAM OF GOOD EXPERTS WILL SUCCESSFULLY PREPARE AND SUBMIT FDA MEDICAL DEVICE REGULATORY DOCUMENTS FOR THEU.S AND INTERNATIONAL CUSTOMERS.

  4. THANK YOU For more information about Medical Device Regulations please feel free to contact : enquiry@operonstrategist.com Or Visit : https://operonstrategist.com Call Us Now : 9028043428 | 9370283428 | 9325283428 Address: Office 14, 4th Floor, MSR Capital, Morwardi Road, Pimpri Colony, Pimpri, Pune 411018

More Related