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Assess your QMS Readiness Now.
Unlock your organization’s quality management potential with our quick, expert‑designed QMS Status Assessment Test. Identify strengths, uncover gaps, and get actionable insights tailored to elevate your compliance and audit readiness. This self‑assessment is aligned with core EU MDR Article 10(9) QMS expectations as well as ISO 13485 principles, so you can see how close your system is to regulatory readiness. Take control of your quality system today and ensure regulatory excellence with confidence.
Regulatory Submission Readiness.
This tool is designed to help you systematically verify that your medical device submission package is complete, compliant, and prepared for timely regulatory approval. By completing it, you can identify gaps requiring attention before submission. The checklist covers critical elements, including dossier structure, device classification, technical and clinical documentation, risk management aligned with ISO 14971, labeling and Instructions for Use, software validation (if applicable), and quality management system documentation, as well as EUDAMED actor/device registration and UDI assignment where required under EU MDR.
Use this checklist to ensure all submission components are in order. Early identification of missing or incomplete items enables you to assign responsibilities, streamline your regulatory process, and enhance confidence in your submission’s success.
Clinical Evaluation Report (CER) Preparation Checklist.
This tool supports thorough preparation of your Clinical Evaluation Report (CER) in accordance with EU MDR Annex XIV Part A and MEDDEV 2.7/1 Rev. 4, and is informed by key MDCG guidance documents such as MDCG 2020‑1, 2020‑5, and 2020‑6 where applicable. It offers a stepwise approach for verifying that all relevant elements—from literature analysis and data documentation to risk‑benefit justification—are properly addressed, and highlights links to related deliverables such as the Summary of Safety and Clinical Performance (SSCP) for Class III and implantable devices.
Use the checklist to monitor progress, confirm the inclusion and quality of necessary evidence, and keep track of revision status throughout CER development. By systematically recording each section's completion and reviewer insights, you ensure compliance and facilitate effective teamwork, expert involvement, and future updates aligned with regulatory standards.
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