Software, Systems, Quality, and Regulatory
Medical Device
Medical Device
Medical Device
- ISO 13485, ISO 14971, IEC 62304
- IEC 82304, IEC 62366, IEC 81001
- 21 CFR Part 820, 21 CFR Part 11
- SiMD, SaMD, GxP, EU MDR & IVDR
- Development/Test, V&V, CSV
- Cybersecurity, AI/ML/DL/NN/FL
- Program Management
- Project Management, Product
Aerospace
Medical Device
Medical Device
- DO-178, DO-254, DO-160
- DO-330, DO-331, ISO 9001
- MIL-STD, ITAR, ARINC
- Software, Systems, Hardware
- Development/Test, V&V, CSV
- Cybersecurity, AI/ML/DL/NN/FL
- Program Management
- Project Management, Product
Compliance
Medical Device
Compliance
- ISO 13485 Audit & Remediation
- ISO 14971 Audit & Remediation
- ISO 62304 Audit & Remediation
- DO-178 Audit & Remediation
- DO-254 Audit & Remediation
- Gap Analysis, SOPs, Templates
- QMS, DHF, DHR, DMR, CAPA
- 510k, FDA, MDR Submissions