Poojapandit

Operon Strategist the leading medical device regulatory consultant providing consultation for 21 CFR 820.30 design control with extensive experience and the practical implementation of design controls regulation for developing new design control processes or for making improvements to existing processes. We assist in design controls as per FDA and ISO 13485:2016 that can be mapped to the process that works best for the organization and the product being developed. If you need any help setting up a design control system, or wish to modify an existing system in order to align with ISO 13485 or

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 stag