Regulatory Affairs Consulting Services
- Regulatory Strategy
- Product Classification
- Pre-sub (Q-Sub)
- Device Registration and Listing
- Submissions
- 510(k)
- PMA
- IDE
- Medical device research studies
- EU MDR Guidance and Documentation
- Clinical Evaluation Reports (CER)
- CE Mark approval processing
- Post-Market Clinical Follow-up (PMCF) studies and reports
- Post-Market Surveillance (PMS)
- Gap analysis
- Clinical Research Study
Project Management Consulting Services
- Product development phase support
- 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 in the development and writing of Study Protocols, Consents, Literature analysis, and Clinical Evaluation Reports.
Talent Recruitment Consulting Services
- Support with talent screening, job writing and posting, interview set-up and coordination.
- Our talent recruitment team are experienced professionals within Medical devices with intimate understanding of Regulatory Affairs, Clinical Research and Project Management.
- Our customized approach allows us to recruit the right talent for your organization.
Serving clients remotely all over the United States.