📑 Daniele Perl-Treves, PhD (Weizmann Institute of Science), brings over 20 years of expertise in the medical device industry, ensuring the successful preparation of regulatory and clinical documentation.
✔️Specializing in crafting Clinical Evaluation Reports (CER) for all device classes, Daniele has a proven track record of submissions accepted by CE Notified Bodies.
📝 Expert in developing PMS documentation, including PMS plans, PSURs, and PMCF plans/reports.
⚖️Daniele ensures compliance with stringent regulatory standards.
🚀 A hands-on background in wet lab procedures enhances proficiency in IVDR and preparation of Performance Evaluation Reports (PER), delivering high-quality, accurate submissions that support device innovation and market success.
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