Regulatory Medical Writer — Systematic Literature Review & SOTA (EU MDR Class IIa CER)

PROJECT OVERVIEW We are an established European FemTech / women's health medical device company. We are developing a new Class IIa medical device: an intravaginal probe delivering electrical muscle stimulation (electrostimulation) for pelvic floor rehabilitation (e.g. management of urinary incontinence and pelvic floor muscle weakness in women). To support the Clinical Evaluation of this device under the EU Medical Device Regulation (MDR) 2017/745, we need an experienced regulatory medical writer to produce a rigorous, fully traceable Systematic Literature Review (SLR) and State of the Art (SOTA) report. This deliverable will feed directly into our Clinical Evaluation Report (CER), so it must be built to withstand Notified Body scrutiny. This is a documentation and evidence-synthesis assignment, not a marketing or clinical-study task. SCOPE OF WORK You will design and execute a systematic literature review and produce a State of the Art report covering, at minimum: 1) The clinical condition and its management - pathophysiology, epidemiology, current standard of care and treatment pathways for the target indication(s), including the role of pelvic floor muscle training and electrostimulation. 2) State of the Art of the technology - established therapeutic alternatives (conservative, device-based, pharmacological, surgical), benchmark/equivalent devices on the market, and current clinical guidelines and consensus. 3) Clinical evidence on electrostimulation for pelvic floor rehabilitation - safety and performance/efficacy data, including known benefits, risks, side effects, contraindications and residual uncertainties. 4) Identification of the acceptable safety and performance benchmarks the device should be measured against, to inform the benefit-risk determination. METHODOLOGY REQUIREMENTS The review must follow a documented, reproducible methodology aligned with: - MEDDEV 2.7/1 Rev 4 (clinical evaluation) - literature search and appraisal principles. - MDCG 2020-6 - sufficient clinical evidence and SOTA expectations. - MDR 2017/745, Annex XIV Part A - clinical evaluation and literature review requirements. - Recognised SLR reporting standards (PRISMA flow and reporting). DELIVERABLES 1) Literature Search Protocol (defined before running the searches): research questions (PICO where relevant), databases (e.g. PubMed/MEDLINE, Embase, Cochrane), full search strings, inclusion/exclusion criteria, and appraisal method - submitted for our approval before execution. 2) State of the Art and Systematic Literature Review report (Word, editable, English), including PRISMA flow diagram, critical appraisal of each retained article (relevance + methodological quality weighting), evidence/extraction tables linking each source to the conclusions it supports, and a full reference list (Vancouver style, with DOIs/PMIDs). 3) All retained full-text articles and the raw search exports (screening spreadsheet with reasons for exclusion). 4) One round of revisions after our internal review. REQUIRED QUALIFICATIONS - Demonstrated experience writing Clinical Evaluation Reports (CER) and literature reviews for EU MDR medical devices - please cite examples (device class / therapeutic area; redacted samples welcome). - Working knowledge of MEDDEV 2.7/1 Rev 4, MDCG 2020-6 and MDR Annex XIV. - Proven ability to run systematic literature searches (PubMed/Embase/Cochrane) and apply PRISMA. - Strong scientific/medical background (life sciences, medicine, physiotherapy, biomedical engineering or equivalent). - Native or fully fluent written English. NICE TO HAVE - Experience in urogynaecology, pelvic floor rehabilitation, women's health, or electrostimulation/physical medicine. - Prior work reviewed/accepted by an EU Notified Body. PLEASE ANSWER IN YOUR PROPOSAL 1) Briefly describe one CER literature review you personally wrote for an EU MDR device: device class, therapeutic area, and your specific role. 2) Which databases and appraisal method would you use for this project, and why? 3) How do you ensure the search is reproducible and Notified-Body defensible? 4) Your fixed price and timeline, and your availability to start. 5) Confirm you are comfortable signing an NDA before receiving device-specific documentation. Note: full device description, intended purpose and IFU are shared only under NDA after shortlisting.