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Welcome to SmartPath

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. At SmartPath, we offer management consulting services to provide you with a fresh perspective and guide you toward success.

Let us support you on your journey!

What we

Our expertise lies in providing management consulting services throughout the entire lifecycle of a medical device, from investment and development to ongoing management.

With a process-based approach, we are equipped to assist in a wide range of medical applications, such as cardiovascular, orthopedics, dental, wound management, and regenerative medicine. Our team has extensive experience in problem-solving for medical device companies that encounter challenges in development, manufacturing, or regulatory compliance.

When faced with resource or expertise limitations, we can step in and take over specific aspects of your medical device development. Additionally, we offer our insights as subject matter experts to investors during due diligence processes or when there is a need to rescue an investment.

Our track record includes successfully developing various medical devices, including implantable and regenerative devices, across diverse medical fields.

Are we
right for

We offer comprehensive services for medical device development and life cycle management. Whether you are in the investment phase, actively developing a medical device, or looking to position your existing device in the market, we are here to provide the assistance you need.

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

Business Consulting for Investors

Whether you are planning to invest or have already made investments, our consulting services are designed to support you throughout the entire process. From conducting due diligence to guiding you through developmental and regulatory challenges, all the way to the commercialization phase, ensuring that you have the necessary strategies and insights to successfully bring your medical device to market.

R&D for Medical Device Companies

If you have a product idea but find yourself missing critical competencies within your development or want to outsource certain aspects of your medical device development, we have the knowledge and experience to support you navigate through these tasks successfully.

Services for Dental Companies

With our team's extensive experience in developing pioneering technical solutions that have set market trends, we possess a deep understanding of the evolving landscape of dental products and the necessary development updates they require. We are well-versed in the latest advancements and innovations in the dental industry as well as the process improvements to ensure your dental products are at the forefront of the market.

eQMS System Implementation

We offer a structured implementation of your Quality Management System (eQMS). Our strategic plan involves a phased approach tailored to your company's growth trajectory. Through systematic integration of QMS components in distinct phases, we ensure each stage is optimized, reflecting our dedication to quality and fostering sustainable organizational development.

SmartPath offers a comprehensive range of services to support medical device companies throughout the research, development, and regulatory processes to ultimately support clients in bringing safe and effective products to the market.


Our management team brings extensive experience in developing and commercializing medical devices across various company sizes, from startups to medium and large enterprises. We are well-versed in the regulatory and developmental challenges startups often encounter, as well as the organizational hurdles that larger companies face during process development. Our expertise includes successfully guiding multiple devices from the initial stages to mass production by implementing intelligent manufacturing processes.

We have a strong proficiency in updating product portfolios to ensure compliance with the Medical Device Regulations (MDR). Furthermore, our team has valuable experience serving as regulatory and R&D experts during due diligence processes. Whether it involves open innovation, joint ventures, or M&A activities, we can provide comprehensive support and insights to evaluate the regulatory pathways and technical aspects of your projects.

At SmartPath we understand the importance of efficient planning, organization, and coordination to achieve optimal results, that’s why project management is at the core of our services and it’s the primary tool to ensure the successful execution of your initiatives.


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