Welcome to SmartPath

We offer management consulting to provide you with a fresh perspective and guide you toward success.

Let us support you on your journey!

Who We Are

We understand that a medical device project can often encounter challenges in terms of development, regulatory compliance, and commercial viability. That’s where we come in.

Are we for right you?

Our consulting services are tailored to meet your specific requirements and challenges within your project, ensuring that you receive targeted support throughout your journey.

Testimonials

We’ve collaborated with SmartPath on multiple projects, and their strategic approach to FDA compliance has consistently streamlined the path to market of our mutual clients.

Taras Bouzakine, Director RA
Valerie Defiesta, Executive Director RA
Veranex

We approached SmartPath with a last-minute request for Biological Evaluation Reports to meet our MDR conversion deadline. Despite the tight timeline, they not only delivered on time but exceeded our expectations. The reports were completed faster than anticipated, allowing us to save both time and costs. Their expertise and commitment were crucial in helping us navigate this critical phase seamlessly

Avital Bar-Lev
VP QA/RA
Noris Medical

SmartPath’s invaluable support nurtured Polaroid Therapeutics’ startup journey. As a compact team with big dreams, their flexible expertise seamlessly filled gaps, propelling us forward. From regulatory guidance to project management through the implementation of quality system, SmartPath has been an indispensable partner in shaping our success story.

Ran Frenkel CEO & Anne Graham COO
Polaroid Therapeutics GmbH

Thank you, SmartPath AG!
Your immediate expert support helped two of my clients clear crucial FDA hurdles, ultimately saving both from financial collapse.
Couldn’t ask for a more dependable partner in a critical moment!

 

Dr. Stefan Holst
CEO
NuVen AG

I am a client of SmartPath’s Dr. Jessica Gilganbach and have been exceedingly satisfied with their [her] professionalism, skill, dedication, knowledge, sincerity, hard work, and, most importantly, patience and understanding. Since our first meeting, we have developed a wonderful working relationship that extends beyond that of client-consultant. Jessica cares very deeply about our project, which is reflected in the outstanding research and presentation deck that she created, and in her continued support. Jessica and SmartPath have been present at every meeting with investors, manufacturers, and distributors, facilitating thorough, productive interactions. If one is seeking assistance translating ideas into reality, I can think of no better partner than SmartPath for the job.

Dr. Harris Saltzburg
OROSCOPE

SmartPath has played a crucial role in our mission to enhance healthcare through AI-powered software diagnostics for neurodegenerative diseases. They provided invaluable support in developing our classification and regulatory strategy, bringing us closer to reaching patients in need. Thanks to their guidance, we have gained a competitive advantage by aligning our innovative approach with relevant regulatory frameworks.

 

Giancarlo Faglia
Partner
Tivenix SA