Recent Projects
Partnering with our team of experts allows you to focus on your business while we handle the rest.
Scroll Through the List Below and Review Some of Our Most Recent Projects
510(k) for a China-based Nystagmograph manufacturer
510(k) for a Florida based 3-D orthodontics software developer
Biocompatibility Test lab interface for a Japanese tonometer manufacturer
EU Regulatory strategy for an Oregon based Medical Device Manufacturer
Preliminary Regulatory Assessment for a California based Alzheimer's biomarker detection
Preliminary Regulatory Assessment for a California based sleep apnea developer
Preliminary Regulatory Assessment for an Oregon based developer of a magnetic resonance diagnostic device
Quality system, 510(k) and EU regulatory strategy for a Maryland based anti-snoring developer
Quality System for Combination Product for a Japan-based, China-based manufacturer in support of a New Drug Application (NDA)
Quality system for a California based Initial Importer
Quality system for a Washington based Initial Importer
Quality Design Control and manufacturing support for an Oregon based IVD Diabetes Testing
Quality system support for an Oregon based Acoustic Cardiography developer
FDA readiness assessment for a Missouri based pharmaceutical and medical device manufacturer
FDA recall communications for a Japanese manufacturer
FDA recall communications for an Oregon based dental equipment manufacturer
FDA 483 remediation strategy for an Oregon based dental equipment manufacturer
FDA 483 response and complete quality system for an Oregon based dental supply manufacturer
