Oriel STAT Analysis

Consulting Firm

Oriel STAT Analysis is a distinguished consulting firm specializing in FDA 510(k) regulatory consulting. With 12 years of dedicated experience, they excel in providing robust biostatistics and meticulous testing planning for 510(k) submissions. Oriel STAT Analysis empowers medical device companies to expertly navigate FDA regulatory pathways, ensuring successful 510(k) clearances. Their expertise ...

Experience: 12+ years

Professional Overview

Oriel STAT Analysis is a distinguished consulting firm specializing in FDA 510(k) regulatory consulting. With 12 years of dedicated experience, they excel in providing robust biostatistics and meticulous testing planning for 510(k) submissions. Oriel STAT Analysis empowers medical device companies t...

Core Specializations

Best suited for

• • MedTech companies seeking expert regulatory guidance

Experience signals

• Background: 12+ years of regulatory experience.

Cruxi view

Oriel STAT Analysis distinguishes itself through a focused expertise in biostatistics and testing planning specifically tailored for FDA 510(k) submissions. With 12 years of experience, the firm offers specialized consulting services to medical device companies navigating the 510(k) clearance process, covering device classes I, II, and III. Their strength lies in providing robust statistical analysis and test strategies, crucial for demonstrating substantial equivalence and achieving successful FDA clearances. The firm's fixed-project pricing structure offers clients predictable costs, enhancing budget planning.

This analysis is generated by Cruxi AI using public information and may not capture the full scope of the consultant's experience.