Manufacturers of medical devices require high-quality system and software development. Standards such as ISO 14971 (risk management), ISO 13485(QM), IEC 62304 (life-cycle), IEC 60601 (product development), Medical SPICE, and FDA place high demands on risk management and software quality. Vector offers medical device manufacturers professional support in product development, requirements engineering and change management. Our Software Quality Analysis (SQA) and cybersecurity solutions Grey-Box Penetration Test for medical devices achieve high defect detection and robust hardening.
Vector Consulting Medical Solutions
- Medical Software Dev Training: comprehensive overview of medical software engineering principles
- Cybersecurity Testing: rigorous testing to strengthen system security against cyber threats
- Process Improvement: utilize Medical SPICE and agile processes for improved development processes
- Quality Management: adherence to ISO 13485 standards
- Risk Management: implement ISO 14971-compliant strategies
- Agile for Medical:streamline operations, boost efficiency, and reduce cycle times using agile methodologies
- IEC62304 Compliance: Master the IEC 62304 standard for medical software development
- Supplier Management: efficiently manage suppliers, conduct audits, and foster global collaborations
- Requirements Engineering: improve requirements engineering and product management
- Code Quality Analysis: ensure code integrity and reliability for your medical software
