克服当今主要监管挑战的行之有效的方法

Sponsored byMichael Thomas, Innovasis IncSharon Starowicz, OSMA FellowRyan Belaney, Phoenix KineticsProven Ways to Overcome Today's Top Regulatory ChallengesProven Ways to Overcome Top Regulatory ChallengesOSMA: Addressing Challenges as an IndustryThe Orthopaedic Surgical Manufacturers Association (OSMA) is a nonprofit organization composed exclusively of manufacturers specializing in orthopaedic surgical appliances, implants, instruments, equipment, and orthobiologics. OSMA is one of the longest-standing trade associations devoted to the manufacture of medical devices used in orthopaedic surgical procedures.OSMA Member CompaniesOSMA Mission: Striving to meet our vision through the following strategic objectives Session Agenda•The Use of Real-World Evidence for Regulatory Submissions•Orthopedic Alliance Roundtable•MR Testing and LabelingProven Ways to Overcome Top Regulatory ChallengesReal-World EvidenceIntroduction: Real-World Data (RWD)/Real-World Evidence (RWE)Challenge: Leverage R