FDA Registration FAQ’s

 FDA is an agency within the US health and welfare department, a regulatory body which provides some guideline for setting up the plants of medical devices. FDA registration FAQs

What is FDA and FDA Registration? 

FDA is Food and Drug Administration Agency formed for consumer’s safety and security. Any medical device manufacturer who wish to sell their product in USA market or the exporter’s and importer’s at their initial stage should register them with FDA. The registration of product depends upon the Class of the device. we the team of Operon strategist help and guide medical device manufacturer in FDA Registration process. 

What are the Roles and responsibilities of FDA? 

FDA’s prime intention is to protect public health by ensuring safety and security. FDA always take initiatives for innovation which favors the public health and safety. 

What type of product needs FDA approval? 

Whether I need FDA’s Approval or not? 

Are FDA and ISO same? 

On what basis medical devices are classified? 

What is cost of FDA approval? 

How will I get FDA approval? 

Is FDA approval and FDA registration same? 

Is FDA registration process time taking? 

Read More – FDA registration FAQs

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Contact details –

Phone no –  9325283428

Mail  – dm@operonstrategist.com

If  You Want Medical Devices Services Consultation For Following.

Medical Device Consulting

 cdsco registration

 FDA 510k Clearance

 ce mark medical device

 CDSCO Manufacturing License 

CDSCO import license 

TURNKEY PROJECT CONSULTANT 

medical device manufacturing

 iso 15378 certification 

21 cfr part 210 and 211

ISO 13485 Medical Device Consultant 

Primary Packaging Turnkey Project Consultant

Clean Room Design Consultant 

manufacturing site conceptualization 

Market Analysis and feasibility for Medical Devices 

manufacturing plant layout design 

medical device design and development

DMF file submission guideline

21 cfr part 820 

qms certification services

capa management 

design control requirements 

medical device process validation 

combination product 

continuous improvement program 

Medical Device Compliance & Regulatory Services 

Cdsco India authorized agent for medical device  

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