Our MedTech Consulting Solutions at a Glance
Consulting Solutions for Security, Compliance and Efficiency
Vector Consulting for Medical Industry
Medical device development faces multiple challenges, including rising cyberattack threats, extensive regulatory requirements, agile development needs, efficient process management and pressure to reduce R&D costs.
Vector Consulting supports the efficient use of standards for regulatory compliance with FDA and MDCG guidelines, as well as development standards such as IEC 62304, ISO 14971 and IEC 60601. We also support agile methodologies and cybersecurity through independent penetration testing of medical devices.
To address these demands, we deliver aligned development and lifecycle processes including robust cybersecurity and safety measures from design to deployment and software update management. This includes strengthening system architecture, structured risk management, requirements engineering, traceability and cost-effective R&D while ensuring safety and security throughout the product lifecycle.
Vector Consulting Services provides hands-on consulting and services for the development and testing of medical systems — from requirements to post-market maintenance.
Your Advantages with Vector Consulting
- Regulatory compliance by efficiently adapting to increasing regulatory scrutiny, such as FDA and MDR regulations
- Complete consulting support from requirements engineering to testing and post-delivery
- Process improvement, change management, cost optimization and technology adoption
- Continuous competence development through trainings and hands-on consulting in critical projects
- Comprehensive security strategies covering threat intelligence, vulnerability management, security-by-design and lifecycle security
- Independent risk-oriented penetration testing lab
- Sustainable and measurable results tied to your medical device objectives
- AI-based methodologies and assets, such as GenAI-based risk assessment, requirements and test optimization, and BOM-based vulnerability scanning
- DevSecOps and rapid recovery from cyber incidents, including continuous monitoring and security integration into the development process
Our Key Solutions for MedTech
Medical Security
Security of medical devices is essential because they handle both patient health and sensitive data. Vector security solutions for medical devices focus on systematic, risk-oriented methods to ensure that security efforts address the most significant risks.
Security-by-Design
- Promoted by safety-driven development
- Critical systems should be secure by design
- Frontloading from requirements to engineering
Security-by-Lifecycle
- Based on experience in IT and software systems
- Adds to the traditional Security-by-Design approach
- Addresses dynamic changes in threats and security mechanisms
MedTech Verification and Validation
Vector Consulting uses TARA to achieve Grey-Box Pen Testing across the lifecycle. We apply a 10-step approach for Grey-Box cybersecurity testing using the Triple Peak Model.
Since testing is one of the most expensive and least organized activities across companies, we increasingly use risk-based V&V methods to improve effectiveness, efficiency, transparency and cost reduction.
- Verification methods include design reviews, code inspections, code analysis, configuration reviews, integration testing and system testing
- Validation methods focus on performance testing and usability testing
- Cybersecurity testing includes risk assessments, vulnerability scans, fuzzing and penetration testing
