Review, Remediation, or Crafting from Scratch

Whether you already have existing technical documentation or need to start from scratch, we are here to assist you every step of the way. We can review your current documentation, identify gaps, and provide remediation support to ensure compliance with the EU MDR. Alternatively, we can craft the entire document from scratch, tailoring it specifically to your device and regulatory requirements.

How Can We Support

Technical Documentation for CE Marking: Covering every aspect of technical documentation and design dossier, our services encompass all essential elements, including risk management, clinical evaluation, labelling, Instructions for Use (IFU), General Safety and Performance Requirements (GSPRs) checklist and more. We meticulously address each requirement to ensure your documentation is comprehensive, accurate, and aligned with the EU MDR.

Clinical Evaluation Plan and Report: Collaboratively, we support you in developing a comprehensive Clinical Evaluation Plan (CEP) that outlines the strategy for collecting and analysing clinical data and preparing the Clinical Evaluation Report (CER) that succinctly presents findingsderived from pertinent data sources. 

Literature Search Protocol and Report: We establish a detailed Literature Search Protocol (LSP) that outlines the search strategy, inclusion and exclusion criteria, databases utilized, and search terms appropriate for your device, and then conduct systematic searches, retrieve pertinent articles, screen them, critically appraise them, analyse them and prepare the Literature Search Report (LSR), ensuring a comprehensive and well-documented process. In essence, we shoulder the burden of navigating through the scientific literature for you. 

PMCF Plan and Report: We provide assistance in developing a comprehensive PMCF Plan that encompasses the strategy for collecting data on your device’s safety and performance after its market release, which includes defining objectives, study design, data collection methods, and an analysis plan. If needed, we can prepare the PMCF Report, which summarizes the findings, analyses real-world data, and evaluates your device’s ongoing safety and performance in the market for you.