Simplifying Compliance, Accelerating Innovation
Expertise in both product development and compliance evaluation
In-depth understanding of IEC 60601-1 requirements
Guidance at any stage—from early design to final testing
Practical, actionable solutions tailored to your needs
Expertise in both product development and compliance evaluation
In-depth understanding of IEC 60601-1 requirements
Guidance at any stage—from early design to final testing
Practical, actionable solutions tailored to your needs
About US
Experience You Can Trust
With years of experience in medical device development and compliance evaluation, Brian Epp founded True Path Compliance Partners to help companies navigate the complexities of IEC 60601-1 certification.
About True Path Compliance Partners
Brian Epp, Founder & Principal Consultant
Services
Expert Guidance at Any Stage of Development
Every medical device company faces different compliance challenges. Whether you’re just getting started or preparing for final certification, True Path Compliance Partners provides tailored support to ensure a smooth path to IEC 60601-1 compliance.
Our Mission
Empowering Innovation Through Compliance
We are dedicated to helping medical device companies bring safe, compliant products to market efficiently. By simplifying the compliance process, we enable innovators to focus on what matters—developing life-changing medical technologies.
Simplified Compliance Process
We take the complexity out of IEC 60601-1 compliance, allowing you to focus on innovation.
Faster Market Access
Our expertise ensures your medical devices meet safety and regulatory requirements efficiently.
About True Path Compliance Partners
BRIAN EPP,
Founder & Principal Consultant
Testimonials
What our Clients say About us
Brian’s in-depth knowledge of IEC 60601-1 compliance was invaluable during our product development. His guidance allowed us to navigate the certification process with confidence and efficiency.
"We were struggling with last-minute compliance issues before testing, but True Path Compliance Partners provided hands-on support that ensured a smooth evaluation. Their practical solutions made all the difference!
How do we get started?
Reach out via phone, email, or the contact form, and we’ll schedule a consultation to discuss your specific needs.
FAQs
Have Questions? You Can Clarify Here
Our FAQs address common concerns about IEC 60601-1 compliance, helping medical device companies navigate the certification process with ease. Whether you’re in the early stages of development or preparing for final testing, our expert insights ensure you stay on the right path.
IEC 60601-1 is an international standard ensuring the safety and performance of medical electrical equipment. Compliance is often required for regulatory approval and market access.
The earlier, the better. Planning for compliance during the early development stages helps avoid costly redesigns and delays later in the process.
We work with both startups and established medical device companies. Whether you’re developing your first device or refining an existing product, we can help you navigate IEC 60601-1 requirements.
Yes. We provide on-site support during IEC 60601-1 evaluations to help address issues in real time and ensure a smooth testing process.
Reach out via phone, email, or the contact form, and we’ll schedule a consultation to discuss your specific needs.
True Path Compliance Partners made the IEC 60601-1 certification process seamless for our team. Their expertise helped us identify potential compliance gaps early, saving us both time and resources. Highly recommended!