CREATIVE SOLUTIONS TO PAVE THE PATH TO THE MEDICAL DEVICE MARKET
Regulatory Strategy
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Strategic planning for Medical Devices & IVDs
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Intended Use and Indications
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Product classification
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Regulatory Pathway
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Predicate device
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Performance requirements, standards, and guidelines
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Clinical and preclinical requirements to support claims
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Regulatory assessment of product changes (LTF/submission)
FDA -Pre Submission
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Preparation and Submission of Regulatory Binder
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Pre-Sub, 510(k), De Novo, IDE, Breakthrough Device Application, EUA
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Establishment Registration and Device Listing
CE Mark & Registration
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Technical File preparation- MDR or IVDR
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Clinical Evaluation Plan and Report (CEP, CER)
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Post Market Surveillance (PMS) and Post-Market Clinical Follow-up (PMCF)
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Vigilance: MDR, FSN, FSCA, Recall
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Global Registration: LATAM, Canada, APAC, Israel
Clinical Studies
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Strategic and study design
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Creation of clinical study protocol
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Scientific review
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Compilation of Clinical Investigation File
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Submission to ethics committees and regulatory authorities
About Dalia Givony
Ms. Givony is a regulatory and clinical affairs professional with 20 years of experience in global regulatory and clinical studies of medical devices, including 7 years in executive RA & Clinical management positions at Medtronic.
She holds a Master’s degree in Biomedical Engineering from the Technion (Haifa, Israel) and has practical experience in the medical device development process, risk management, addressing user and business needs, as well as understanding clinical environments.
Ms. Givony specializes in innovative regulatory strategy, FDA premarket submissions, compiling the Technical File binder for CE marking, and managing clinical study planning, the approval process, and execution.
With extensive experience in written interactions and meetings with the FDA and Notified Bodies, she has successfully led efforts that resulted in creative, less burdensome solutions, successful submissions, and marketing clearances—always taking broader business aspects into account.