Medical Device
Vi-Leon places top talent across every function of the medical device industry, from concept through commercialization.
Types of Projects We Support
Regulatory Changes
EU MDR, UKCA, FDA transitions, and evolving global compliance requirements
Mergers & Acquisitions
Quality system integration, due diligence support, and post-merger harmonization
Site & Product Transfers
Manufacturing transfers, tech transfers, and product line relocations
Remediation & Consent Decrees
Warning letter response, 483 remediation, and FDA enforcement actions
New Product Launches
First-in-class submissions, design validation, and market entry support
Quality System Buildouts
QMS implementation, gap assessments, and ISO 13485 certification support
Audit Preparation
Notified body inspections, FDA audits, and internal readiness assessments
Facility Startups
Greenfield builds, equipment qualification, and new site commissioning
Industry Verticals
Quality
- Quality engineering
- Quality assurance
- CAPA management
- ISO 13485 / 21 CFR Part 820
- Audit readiness
- Validation & verification
Regulatory
- 510(k) & PMA submissions
- FDA / EU MDR compliance
- Regulatory strategy
- Technical documentation
- Post-market surveillance
- Labeling & advertising
Technical Engineering
- Mechanical & electrical design
- Software / firmware (SaMD)
- Design controls
- Process development
- Prototyping & testing
- Systems engineering
Microbiology
- Biocompatibility (ISO 10993)
- Sterilization validation
- Microbial testing
- Cleanroom operations
- Environmental monitoring
- Sterility assurance
Project Management
- Program & project management
- Product lifecycle management
- Cross-functional team leadership
- Stage-gate & milestone tracking
- Risk & issue management
- Change control
Request a Medical Device Consultant
Looking for specialized talent in quality, regulatory, engineering, microbiology, or project management? Fill out the form and we'll find the right fit, fast.
