Olena S.

I'm a Senior Medical Writer with 4+ years of hands-on experience in regulatory documentation for medical devices and pharmaceuticals across all risk classes (I, IIa, IIb, and III), including sterile medical devices. Core Expertise: • Authoring and adapting regulatory documentation in full compliance with MDR (EU) 2017/745 • Developing comprehensive Clinical Evaluation Plans (CEPs), Clinical Evaluation Reports (CERs), Summaries of Safety and Clinical Performance (SSCPs) • Creating Post-Marketing Clinical Follow-Up (PMCF) plans and reports • Writing and optimizing Instructions for Use (IFU) • Conducting benefit-risk assessments according to ISO 14971 • Developing systematic Literature Search and Review Protocols in accordance with MEDDEV 2.7/1 rev. 4 • Executing comprehensive literature searches across medical databases (PubMed, Embase, Cochrane) • Performing critical appraisal of scientific literature using validated methodological quality assessment tools, including Cochrane Collaboration's Risk of Bias tools for Randomized Controlled Trials (RCTs) and MINORS (Methodological Index for Non-Randomized Studies) • Creating detailed literature review documentation including search flow diagrams (PRISMA), data extraction tables, and analysis summaries for clinical evaluation and post-market surveillance procedures Advanced Capabilities: • Proficient in EndNote 21 for comprehensive reference management, including organizing and tracking literature sources, generating formatted citations, and maintaining bibliographic databases according to regulatory requirements • Authoring detailed mechanism of action descriptions for medical devices within technical documentation and clinical evaluation reports • Conducting equivalent/similar device searches and creating equivalence tables • Analyzing safety and efficacy of active ingredients and excipients during new device development • Writing clinical sections for IFUs: performance characteristics, target groups, clinical benefits, interactions, warnings, contraindications, side effects • Validating marketing claims through literature searches and developing new evidence-based claims • Conducting safety monitoring through multiple databases (MAUDE FDA, FDA Recall, BfArM, MHRA, Swissmedic, DAEN) • Adapting clinical evaluation documents for international regulatory requirements (European countries, Kingdom of Saudi Arabia (KSA), Canada, Brazil, Ukraine, and many others) Device Experience: • Infusion therapy systems: Disposable infusion sets (PR systems) with metal and plastic needles, YF SmartSet intravenous infusion systems, LIGHT-PROTECTIVE YURiA-PHARM systems for intravenous administration. • Transfusion and venous access devices: Disposable blood transfusion sets, U-FLEX Plus peripheral venous catheters. • Inhalation and respiratory devices: Umerox Devicе for inhalation, Umerox Inhal, Breather Barrier, Breather Treat, ULAIZER AIR VP-02, Ectobris, Lorde® hyal, Nasisoft, Okistar hyal 7, ULAIZER, SNOTTY, Sodium chloride nebules. • Wound care & safety products: YU-FiX plasters, YURiA-PHARM surgical plasters, gauze bandages, medical cotton wool, Revul® hemostatic dressings, safe syringes. • Gynaecological and urological products: GINODEK®, Instylan® for intravesical use. • Orthopaedic/viscosupplementation products: Artro-Patch®, Diart® injections. • Dialysis devices: Diavitek PD, Disinfection cap for peritoneal dialysis Diavitek, Extension of the peritoneal catheter Diavitek, Belt for the peritoneal dialysis catheter Diavitek, Acid concentrate for hemodialysis ABC-44, ABC-34, Liquid bicarbonate concentrates for hemodialysis BBC-8,4. • Dermal Fillers: Alexa Medium/Smooth/Volume. • Skin Rejuvenation: Electri 0.55%, XELA REDERM HYALUAL 1.1%. • Administration Devices: 3-way infusion tap, Injection kit, U-SPIKE cannula • Infusion Accessories: 3-way infusion tap My degrees in Biotechnology and Bioengineering (Bachelor's and Master's) provide a solid scientific foundation for analyzing clinical data and conducting thorough literature reviews across medical databases. I'm certified in Clinical Evaluation for Medical Devices, Good Clinical Practice, and Clinical Trials Management. 💡 Let's collaborate to bring clarity, accuracy, and regulatory alignment to your clinical documentation needs!