Providing consulting services within the domain of end-to-end New Product Development of Medical Devices, NorMed Consulting strives to help Medical Device Manufacturers down the least burdensome path to market while keeping patient safety and product quality at the top of the agenda. Device Experience: • Software as Medical Device (SaMD) • Medical Device Software (MDSW) • Digital Therapeutics (DTx) • Artificial Intelligence (AI) / Machine Learning (ML) enabled Medical Devices • Combination Products • IVD Medical Devices Regulatory Affairs: • Regulatory Strategy and Submission • Classification and path to market • Developing Intended Use / Intended Purpose • Person Responsible for Regulatory Compliance (PRRC) • Gap Analysis and Process Mapping (As-is & To-be) • The European MDR (EU) 2017/745 • The European IVDR (EU) 2017/746 • The UK MDR 2002 (SI 2002 No 618, as amended) • The FDAs 21 CFR part 812, part 820 and part 860 Clinical Affairs: • Clinical Development and Clinical Strategy • Clinical Evaluation Plan (CEP) including Clinical Development Plan (CDP) • Clinical Evaluation Report (CER) • Clinical Investigation and Good Clinical Practice (GCP) • Medical Writing Quality Assurance & Design Assurance: • Design Controls • Technical Writing • Risk Management • Requirements Engineering / Management • Human Factors / Usability Engineering • Verification and Validation (VnV)
