Medical
Vector Consulting for Medical Industry
Medical device development faces multiple challenges, including the rising threat of cyberattacks, extensive regulatory requirements, the need for agile development, efficient process management, and pressure to reduce R&D costs.
Vector Consulting provides professional support in the efficient usage of standards for regulatory compliance to FDA and MDCG guidelines, development standards like IEC 62304 (life-cycle), ISO 14971 (risk management), IEC 60601 (product development), etc., in agile methodologies as well as support in cybersecurity by offering independent risk-oriented Grey-Box Penetration Test of medical devices.
Services for Medical
- Standards and Regulatory Compliance: Consulting and compliance support for FDA guidelines, MDCG regulations, IEC 60601, IEC 62304, ISO 14971 etc.
- Requirements Engineering and Product Management: Systematic requirements engineering to ensure consistency of requirements, product usability, risk management, system reliability, and regulatory compliance.
- Cybersecurity Support: Cybersecurity Validation with independent risk-oriented Grey-Box Penetration Test safeguards systems against threats, while Security-by-Lifecycle ensures post-market surveillance through continuous monitoring, incident response, and vulnerability management.
- Trainings: Individual trainings and training programs for customer specific competence development
MedConf Presentation 2025
In this lecture, we will provide field-proven cybersecurity methodologies with examples on how to apply these in medical device development such as risk management with GenAI based TARA, traceability and independent risk-oriented Grey-Box Penetration Test. These approaches are contemplated in context of security-by-life-cycle methods which include post-market surveillance and vulnerability management across the medical device life-cycle.
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