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 Artificial Intelligence Act ('AI Act')
• 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)
• Literature Search and Review
• 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)
Company Details
- Founded
- -
- Address
- Copenhagen, Denmark, Dk
- Industry
- Medical Equipment Manufacturing
- NAICS
-
Medical Equipment and Supplies ManufacturingSurgical and Medical Instrument ManufacturingSurgical Appliance and Supplies ManufacturingDental Equipment and Supplies ManufacturingOphthalmic Goods ManufacturingDental Laboratories
- Website
- http://www.normedconsulting.com
- Keywords
- Regulatory Affairs, Quality Assurance, Design Control, Clinical Evaluation, Human Factors / Usability Engineering, Risk Management, Technical Writing, Medical Writing, SaMD, DTx, AI/ML, MDR, FDA CFR Title 21 Part 820, Marketing Submissions.
- HQ
- Copenhagen, Denmark
Normed Consulting Questions
Normed Consulting's website is http://www.normedconsulting.com
Normed Consulting's LinkedIn profile is https://www.linkedin.com/company/normed-consulting
Normed Consulting's industry is
Medical Equipment Manufacturing
Normed Consulting's top competitors are
Red Medtech,
Rook Quality Systems,
Effectum Medical Ag,
Mwa Consulting,
Medpoint, Llc,
Coloplast,
Qes Medical Llc,
Platypus Medtech Consulting,
Dawn Health,
Cannon Quality Group, Llc.
Normed Consulting's categories are Medical Equipment Manufacturing
Normed Consulting's founding year is 2022
