
Medical Device Industry
Consulting, training and auditing services to help your organization comply with relevant FDA regulations, guidance documents and international standards:
- Compliance with FDA regs, Design Controls, and Guidance documents
- Software development, Verification & Validation
- Compliance with IEC 62304 Software Development Lifecycle
- Risk Management and compliance with ISO 14971
- MDDS development using AAMI SW87 guidance
- Training in Software Development for Medical Device Manufacturers
- Compliance with ASME NQA-1, NRC Regs, and EPRI Guides
- Evaluation of existing software inventory
- Assessment of current software procedures
- Development and execution of Commercial Grade Dedication Plans
- Assessing compliance of software subcontractors to standards and regulations
- Performing risk assessments and identifying safety cases
- Functional, in-process and compliance audits
Nuclear Power Industry
Commercial Grade Dedication services to help qualify software for use in
safety-critical areas:
Transportation Industry
Consulting, training, and auditing services for software used in
safety-critical areas: