BONEZONE

DEC 2016

Published by ORTHOWORLD Inc., BONEZONE delivers strategic sourcing & product commercialization solutions to orthopaedic device company decision makers and their partners.

Issue link: http://bonezonepub.epubxp.com/i/762486

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IMPLANT ©2015 Orchid Orthopedic Solutions LLC REG-1-1 STRENGTH FLEXIBILITY NEW HOPE HEALING HAPPINESS QUALITY OF LIFE SLEEPING NORMAL AGAIN FEELING WHOLE ENERGY STRENGTH FLEXIBILITY NEW HOPE HEALING HAPPINESS QUALITY OF LIFE SLEEPING NORMAL AGAIN QUALITY OF LIFE ENERGY STRENGTH (517) 694-2300 www.orchid-ortho.com Why do we think about regulatory requirements early – from the design stage on? To provide an opportunity for people to live a better life. Working in accordance with FDA and MDD guidelines, Orchid Design's regulatory team can provide the knowledge, preparation and process needed to develop appropriate submission strategies, ensuring compliance and maximizing the opportunity for regulatory clearance success. From strategy development and authoring of all applications, change notifications and responses to adverse event reporting, recall guidance, and Form 483 and warning letter response support, we go out of our way to clear the path to clearance. All with the mission to help others live a better life.

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