MEDICAL DEVICE TRAINING
- ISO 13485 Training
- FDA GMP / cGMP Training
- CE Mark / CE Marking Training
- ISO 14971:2007 Training
- Medical Device Internal Auditor Training
GMP (QSR) & ISO 13485 IMPLEMENTATION
We provide consulting services to help you comply with regulations such as US FDA's Good Manufacturing Practices (GMP) (QSR) and EU's Medical Device Directives (MDD), and comply with international quality standards such as ISO 13485.
- Risk Analysis
- Part 11 Compliance
GMP (QSR) and ISO 13485 IMPLEMENTATION
Specifically, we offer the following expertise:
Develop Policies & Procedures
We help you design and implement GMP quality systems, in compliance with the current and new GMP regulations. We specialize in the computerized documentation systems. GMP (QSR) and ISO 13485 IMPLEMENTATION
Employee Training
We offer on-site ISO/GMP training sessions for your employees. These are tailored for your engineering, manufacturing and quality personnel
Internal & Vendor Audits
We audit your new GMP systems and recommend corrective actions for compliance with the current and the new GMP regulations SOFTWARE QA
We help companies with their software development and validation plans, and we audit their software QA documents. We prepare software documents for 510(k) submissions, and we develop strategies for the FDA's software audits.
- Product or System Specification
- Hazard Analysis
- Software Requirements specification
- Software design documents
- Unit tests/Integration tests
SOFTWARE VALIDATION
- Validation test plan
- Validation test cases
- Validation test results
- Software verification process
Traceability of:
- Hazard elements into requirements
- Requirements into design
- Design into unit tests
- Requirements into validation tests
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