Operon Strategist has a team of trained professionals that work according to set standards and constantly upgrading their work techniques that assure meeting customer requirements timely and as per defined quality standards.
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Phone no - 93702 83428
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Get the right consultation for obtaining the CDSCO manufacturing license for Medical Device in India with Operon Strategist.

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Phone no - 93702 83428

Mail id – [email protected]

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Operon Strategist helps manufacturers develop their quality management system as per the requirements of ISO 15378.

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Phone no - 93702 83428

Mail id – [email protected]

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Operon Strategist the leading medical device 21 CFR 820.30 design control consultants have extensive experience with the practical implementation of design controls regulation for developing new design control processes or for making improvements to existing processes.

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Phone no - 93702 83428

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QMS certification service including QMS certification training, layout designs, manufacturing and postmarket support as we have regulatory expertise in auditing, executing and maintaining all features.

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Phone no - 93702 83428

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An Import license is issued for import of medical devices from other countries to India. Both the foreign company and Indian company jointly need to submit the documentation for the medical device and manufacturing unit.

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Phone no - 93702 83428

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As ISO 13485 consultant we provide guidance about QMS for medical device industries and we make sure that our clients know the benefits of ISO 13485 Certification for their organization.

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Phone no - 93702 83428

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Operon Strategist is FDA 510 k process consultant helps the clients to register SBU (Small Business Unit), if applicable. Take out the testing requirement of the product, creation of the dossier, resolving the queries and after completion of all the activities, the client receives the US FDA 510 k approval.

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Phone no - 93702 83428

Mail id – [email protected]

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Medical devices design and development is the urgent stage for its prosperity. Operon strategist is there to guide you with the design consulting for medical devices.

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Phone no - 93702 83428

Mail id – [email protected]

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