Medical Device Manufacturing

As an ISO 9001:2008 Certified Company, Modern-Tec knows what it takes to implement and follow a detailed and carefully monitored quality assurance program. We are currently a supplier for FDA regulated clients, and consequently we are very familiar with the requirements and expectations of manufacturing in the Medical Device field.

Process Validation

- Measurement System Analysis (MSA)
- Gauge R&R
- Gauge Correlation Studies
- Process Capability
    - SPC/QC CALC (Live Data)
    - Office Buddy
    - Minitab
- Control Plans
- Failure Mode & Effects Analysis (FMEA)
- Batch (Lot) Containment
- Batch Traceability
    - In-process Tags
- First Article Inspections (FAI)
- Machine Maintenance
- Work Instructions
- Production Part Approval Process (PPAP)
- Advanced Product Quality Planning (APQP)