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Mr Anselmo Clay

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Mr Anselmo Clay
  • תחומי התמחות
  • Clay has expertise in Developing Strategic Regulatory Approaches for Products that include Class II &Class III Medical Devices, Drug & Device Combination Products, Human Tissue Products & In-Vitro Diagnostic Products.

Mr. Clay Anselmo (CEO of Reglera LLC.) is a Senior Executive Manager with more than 19 years of experience in all areas of Quality, ISO, FDA Regulatory Compliance and Operations Management in the Medical Device & Human Cellular Products Industries.

Clay has expertise in Developing Strategic Regulatory Approaches for Products that include Class II &Class III Medical Devices, Drug & Device Combination Products, Human Tissue Products & In-Vitro Diagnostic Products. Clay's submissions experience in the US includes PMA’s, 510(K)’s, Pre-IDE’s, IDE’s, RFD’s & 513(G)’s and internationally it includes Technical Files / Dossiers and Canadian License Applications.

Reglera is one of the world's largest and fastest growing regulatory compliance and quality assurance consulting and outsourcing companies serving the medical device and tissue banking industries. Based in Lakewood, CO, USA, Reglera has recently opened a new subsidiary office in Israel, Reglera (Israel) Ltd. This office will act to further enhance the convenience and efficiencies in supporting demand from Reglera's existing Israeli clients and the growing Israeli medical device market.

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