Caroline Guidicelli, MSc, MEng

Caroline began her career in the medical device field as a Manufacturing Engineer for a multinational company selling implantable orthopaedic devices. Following, she worked as a self-employed Medical Writer authoring Clinical Evaluation Reports (CERs). She joined NAMSA in 2019, where the focus of her role is to write and review CERs for compliance with the European Medical Device Directive 93/42/EEC (MDD) and/or with the European Medical Device Regulation 2017/745 (MDR). She has also developed Clinical Study Reports (CSRs) following ISO 14155 and Annual Progress Reports (APRs) for the FDA.

She has worked with numerous manufacturers on all classes of medical devices and a variety of therapeutic areas, including surgical instruments, wound care, orthopedics, dental bone substitutes and neurovascular aneurysm repair. She also participates in the development of templates, work instructions and Standard Operating Procedures (SOPs) for clinical evaluation.

Caroline holds a Master of Engineering in Mechanical Engineering and Polymer Processing, as well as a Master of Science in Innovative Materials.

CORE COMPETENCIES

• High knowledge and familiarity with EU regulatory requirements
• Preparation and review of CERs to MEDDEV 2.7/1 Rev 4 and MDR requirements, such as MDCG 2020-1, MDCG 2020-5 and MDCG 2020-6
• Design and conduct of systematic literature searches (Pubmed, Embase), critical appraisal, clinical data extraction and review of scientific literature
• Preparation and review of Post-Market Surveillance (PMS) plans and Post-Market Follow-Up (PMCF) plans
• Development of clinical evaluation strategy, including CER pathways and MDR transition strategies
• Preparation of Gap Analysis of CEPs/CERs and development of strategies to close gaps
• Addressing non-conformities of CERs from Notified Body audits
• Training on MDR requirements for CERs and development of training materials, internal presentations
• Development of templates, work instructions and Standard Operating Procedures (SOPs) for clinical evaluations
• Supporting the development of CSRs following ISO 14155 and APRs for FDA

RECENT PROJECTS

• 9-month long MDR transition project with a multinational manufacturer; this included creation of multiple CERs, PMS plans and PMCF plans to meet MDR compliance
• Notified Body non-conformities project on CERs for high-risk devices; addressed findings and developed a clinical strategy to close CER gaps
• Development of several CERs for Class III implantable devices following the Well-Established Technology route described in MDCG 2020-6