confinis is a global consulting firm in the field of 1 medical devices, 2 in vitro diagnostics and 3 combination products based in Switzerland and the USA.

We have mastered the theory, but we still see ourselves as practitioners who have learned from scratch.

1 Services

regulatory

regulatory

A well thought through Regulatory Affairs Strategy is at the forefront when it comes to Time-to-Market for your product. You let us know which markets you want to see your product in and our global knowledge about market authorization requirements allow us to define a workable plan to achieve your goals.

2 Services

compliance

compliance

At confinis, our compliance services are designed to ensure your medical devices meet rigorous regulatory standards across various markets. Whether you are navigating the complexities of MDR Article 117 for combination products, aiming for IVDR conformity, or seeking market authorization in Europe, the USA, or other global markets, our expert team provides comprehensive support. We specialize in design control, risk management, usability engineering, and clinical evaluation. From CE marking and FDA registrations to performance evaluations and software considerations, confinis is your trusted partner in achieving and maintaining compliance, facilitating a smooth and efficient route to market for your innovative healthcare solutions.

3 Services

beyond

beyond

At confinis, we go beyond basic compliance to optimize your operational excellence and strategic success. Leveraging cutting-edge technologies and agile methodologies, we streamline and enhance your product development and market strategies. Our specialized support for startups includes tailored regulatory planning and efficient pathway design to accelerate market entry. Furthermore, we can tailor comprehensive e-learning and training programs to empower your team with the knowledge to stay ahead. Extend your capabilities with our additional services such as strategic business consulting, and advanced data analytics for market insights. Embrace the future of healthcare innovation with confinis as your partner in exceeding standards and expectations.

clients

corporate

Our global clients benefit from our expertise in project management, design control, clinical evaluations, human factors, and risk management. We enhance your capabilities through comprehensive training, supply chain optimization, and support in securing market authorizations, ensuring you excel in every venture.

small & mid enterprises

For start-ups and SMEs, we are more than consultants; we are partners in your growth. We build effective quality management systems and secure the necessary market authorizations. Focus on your core innovations while we handle the complexities, ensuring you can operate without distractions.

all others

At confinis, we cater to a broad range of clients, including educational institutions, research facilities, and more. Whether you’re developing cutting-edge medical technologies or improving existing products, we provide tailored solutions that ensure compliance, enhance efficiency, and drive success.

confinis has a team with a very diverse background and we are striving to expand it.

stay up to date with our next events, workshops and webinars.

(EU) 2023/607, 26th May 2024 deadline approaching

The Future of Health Grant welcomes confinis as a new Program Partner

Transitioning to the Medical Device Regulation (MDR) 2017/745