Oriel STAT
is a New Jersey-based consulting firm that provides MDSAP auditing, QMS implementation, private team training, and related services for the medical sector... Read moreOriel STAT
is a New Jersey-based consulting firm that provides MDSAP auditing, QMS implementation, private team training, and related services for the medical sector... Read more
CEO
Alan Marash
News
Mar 31, 2025
Oriel STAT Blog
Oriel STAT Blog Less Than A Year to Go! FDA's New Quality Management System Regulation (QMSR) Is Getting Closer
Mar 11, 2025
Oriel STAT Blog
Oriel STAT Blog Navigating the Impact of EU Regulation 2024/1860 on Medical Device and IVD Manufacturers
Mar 06, 2025
Oriel STAT Blog
Oriel STAT Blog Navigating the Top 6 Medical Device Compliance Issues in the Next 12 Months
Feb 24, 2025
Oriel STAT Blog
Oriel STAT Blog Compliance Requirements for Medical Device Software and Software as a Medical Device (SaMD) in the US and EU
Jan 12, 2024
Oriel STAT Blog
Oriel STAT Blog Medical Device Cybersecurity Requirements Under the EU MDR
Jan 12, 2024
Oriel STAT Blog
Oriel STAT Blog EU MDR PMCF Requirements for Medical Devices
Jan 12, 2024
Oriel STAT Blog
Oriel STAT Blog How to Evaluate, Select Combination Products Suppliers
Jan 11, 2024
Oriel STAT Blog
Oriel STAT Blog 6 Things R&D Engineers Need to Know About the EU Medical Device Regulation
Jan 11, 2024
Oriel STAT Blog
Oriel STAT Blog Understanding EU MDR Clinical Evidence Required for Legacy Medical Devices as Outlined in MDCG 2020-6
Jan 11, 2024
Oriel STAT Blog
Oriel STAT Blog Regulatory Implications of "Reshoring" or Relocating Your Medical Device Manufacturing Facility
