Quality Assurance
and Regulatory Affairs:

Training and Instruction, both in-house and public forum on

- ISO 13485, ISO 9001 and GMP/QSR
- ISO 14971 Risk Management
- MDD/AIMD/IVDD and European CE Marking requirements
- Canadian Medical Devices Regulation and CMDCAS
- Japanese PAL, GMP, GCP and related ordinances
- Process-based Internal Auditing and Supplier Assessments

Third-Party Assessments and Implementation regarding

- ISO 13485, ISO 9001, GMP/QSR
- ISO 14971 Risk Management
- MDD/AIMD/IVDD technical files, Notified Body submissions
- Canadian Medical Devices Regulation, CMDCAS, Device Licenses
- Japanese PAL, GMP, GCP and related ordinances
- Process-based Internal Auditing and Supplier Assessments

Long and Short-Term Project Management regarding

- FDA Consent Decrees, Warning Letters and 483's
- Domestic and International Regulatory Strategies
- Internal Quality Management and Regulatory Support
- Supplier Assessments and Supplier Management Programs
- CAPA and Regulatory Reporting Programs