See some of our provided services below
We offer a wide range of services within the New Product Development space.
Regulatory Affairs
Whether you are seeking FDA approval, CE or UKCA marking, we provide Regulatory Support for both development, submission and post-market activities and help you efficiently communicate with regulatory authorities.
Services include:
- 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 Artificial Intelligence Act ('AI Act')
- The UK MDR 2002 (SI 2002 No 618, as amended)
- The FDAs 21 CFR, Part 820 (the 'QSR')
Clinical Development
Ensuring the safety and effectiveness of your medical device through sufficient clinical evidence and high-quality clinical data has never been more crucial. With our extensive experience in both pre-clinical and clinical domains, NorMed Consulting is equipped to support your Clinical Development efforts across the board.
Services include:
- Clinical Development and Clinical Strategy
- Review & Medical Writing
- Clinical Evaluation Plan (CEP)
- Clinical Development Plan (CDP)
- Literature Search, Review and Reporting
- Clinical Evaluation Report (CER)
- Post-Market Clinical Follow-up (PMCF)
- Clinical Investigation and Good Clinical Practice (GCP)
Quality Assurance
A crucial strategy to reduce overhead and boost product value is by streamlining your product and internal processes to be LEAN, without compromising on quality. At NorMed Consulting, we support this effort by offering assistance in Quality Management System (QMS) development and Design Assurance, ensuring your operations are efficient yet adhere to the highest standards of quality.
Services include:
• Review of technical documentation & Gap-analysis
• Technical Writing
• QMS Development and Optimization
• Internal Audits and preparation
• Design Controls
• Risk Management
• Requirements Engineering / Management
• Human Factors / Usability Engineering
• Verification and Validation (VnV)
• Post-Market Surveillance (PMS)
Product Expertise
Despite being specialist within the domain of Software-enabled Medical Devices, we have solid working knowledge within a wide array of different device types, categories and classes.
Working knowledge include:
- Medical Device Software (MDSW)
- Software as a Medical Device (SaMD)
- Software in a Medical Device (SiMD)
- Digital Therapeutics (DTx)
- AI/ML-Enabled Medical Devices
- Combination Products
- In Vitro Diagnostic (IVD) Medical Devices
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