ACSYS staffing support provides highly qualified, proven professionals to
meet your needs. Each individual has been carefully identified with qualifications specific to project requirements. Our quality
and compliance professional and technology specialists provide valuable assistance achieving corporate strategic objectives. Support
services are provided in the following key areas:
- Quality
Audits
- Internal
- External Suppliers/Contract Service Providers
- FDA Readiness Assessment/Recommendation
- Product/Manufacturing
Transfer, Qualification
- Medical Device Directive 2007/47EC
Compliance
- Assure Technical File Clinical data compliance
- Verification of device classification
- Evaluation of product risks
- Process/Equipment Validation
- Regulatory Submissions
- Quality Control/Assurance
- Procedure Development
- Project Management
- Information Management Systems
- Advanced Programming and Testing
- Infrastructure Systems
- Data Management