Regulatory Affairs Consulting Services
- Regulatory Strategy
- Product Classification
- Pre-sub (Q-Sub)
- Device Registration and Listing
- Submissions (510k, PMA, IDE, NDA)
- EU MDR Guidance and Documentation
- EU MDR Submission
- Clinical Evaluation Reports (CER)
- CE Mark Approval Processing
- Post-Market Clinical Follow-up (PMCF)
- Post-Market Surveillance (PMS)
- Gap Analysis
- Authorized Representative (EU /UK)
Project Management Consulting Services
- Product Development
- Lean Six-Sigma
- Definition of Project Scope, Budget, and Objectives
- Design Input Guidance
- Planning and Risk Analysis
- Streamline Point of Contact
- Project Maintenance and Support
Clinical Research Consulting Services
- Support with Medical Writing (Study Protocols, Brochures, Consents, etc.)
- Literature Analysis
- Clinical Evaluation Reports
- Support with EU MDR Clinical Requirements
Talent Recruitment Consulting Services
- Support with Talent Screening
- Job Writing and Posting
- Candidate Interview Set-up and Coordination
- Consultancy Placement