We have an experienced team of people who help companies /medical device manufacturers in streamlining their pathways for market approval. We have expertise in FDA & EUMDR regulatory compliance and also put efforts into error free deliverables. Feel f...

Operon strategist is medical devices consulting has a good experience in consultation and regulatory expertise for manufacturers and suppliers of medical devices. for any medical device registration process, UKCA marking and licensing you can connect with...

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 processe...

We follow a well-defined work methodology for organized working which leads to zero-errors and higher-efficiency, that assures meeting customer requirements timely and as per defined QMS Certification Standards.

CDSCO issues Medical devices importing license under the Directorate General of Health Services in the Ministry of Health & Family Welfare. Speed up your import licensing process with us; Operon Strategist will assist you at every step of medical devi...

Operon strategist don’t leave you before, we make sure that our customer should get the CE approval with minimal efforts. We've a well- experienced staff of expert engineers and significant knowledge and familiarity with the CE marking process.

We help with the establishment enrollment and device listings to make suitable the supply of medical devices in the US.

We are one of the leading medical device regulatory consultants in Riyadh, Saudi Arabia. We offer clients an array of services like turnkey services, system implementation, training, licensing, regulatory approvals, and certifications for KSA.

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