What We Do

Regulatory Affairs

• Assess strategies for medical device regulatory submission pathways

• Evaluate United States and International country-specific regulations

• Evaluate medical device regulatory requirements

• Evaluate Medical Device Classification – United States and International

• Prepare US FDA Submissions

Pre-submission filing
PMA
de novo

• Prepare US FDA Registrations and Annual Reports

• Prepare EU Submissions

MDR 2017/745
Coordinate with Notified Bodies and EU Representatives

Technical Expertise

• Prepare Technical Files

• Develop Protocols and Reports in accordance to compliance

Clinical Evaluations
Post Market Activities (PMS, PMCF and PSUR)
Biocompatibility
Toxicology
Shelf-Life
Sterilization/Bioburden

• Perform Technical Assessments

Chemical
Engineering
Risk Analysis (ISO 14971)
Statistical Analysis

• Write Position Papers

Regulatory and Compliance interpretations
Scientific and Technical interpretations

• Perform Gap Analysis

Compliance standards version changes and interpretations
Regulatory changes and interpretations
Quality System changes and interpretations