Viken Tech Consulting

With over 15 years of experience in high-stakes engineering, from medical devices and wearable sensors to aerospace and nuclear instrumentation, I bring hands-on expertise and strategic thinking to every project.

I’ve led multidisciplinary teams through complex development and certification journeys. Whether you're preparing for clinical trials, audits, or scale-up, I offer not just advice, but practical, grounded solutions.

Regulatory Strategy & Certification Support

• Certification pathway preparation

• Submission strategy

• Risk management, DFMEA, Fault Tree and QMS setup

• Documentation for authorities and stakeholders

Product & Technical Advisory

• Hardware, electronics, and embedded design guidance

• Mechanical and system design reviews

• Software and hardware architecture compliance

• Safety, performance and functionality validation

Process Optimization

• Design control and V&V process setup

• Technical file gap analysis

• Transition from prototype to scalable product

Flexible Engagement Models

• One-time audits

• Fractional CTO/Product Advisor

• Long-term R&D and certification partner

Cross-Disciplinary Expertise

Mechanical, electronics, software, and compliance. All in one conversation.

Speed Without Shortcuts

Accelerate development without compromising safety or regulatory integrity.

Lean, Practical, Transparent

No fluff. Just what you need to move forward with confidence.

Flexible, Client-Centered Approach

Every company is different. I adapt to your needs,  whether you need a quick regulatory review, hands-on product guidance, or a long-term partner in your R&D journey.