Some of Our MEDICAL DEVICE Services
Regulatory Affairs
- Complaint Handling
- FDA reporting
- Certified Auditing to ISO, FDA
- Corrective Action
- MDR, 510K Submissions
- Develop Regulatory Plan
- ISO Certification support
- Registrations & Licenses
- Post market surveillance
Quality
- Create SOP's, QOP's
- Design Reviews
- QMS Systems
- Quality Manuals
- Risk Management
- Validations
- Job Descriptions
- Create forms, work instructions
Leadership
- Performance Management
- Forecasts
- Strategic coaching, training
- Facilitator
- Re-Organization
- HR and Management Reporting