We are experts in
Medical Devices
The biggest mistakes happen at product conception. Our state-of-the-art analyses and clinical development plans can help you save time and money.
We are experts in
services
Regulatory compliance is about
Creating better devices
Clinical
Our team has broad expertise in clinical research, AI evaluation, digital healthcare products, literature review, trial design, and medical affairs in the health tech sector.
Strategy
We work with AI to assist healthcare companies customizing their global healthcare strategy, considering scientific validity, regulation, health economics, and procurement.
Regulatory
We assist researchers, hospitals, startups, and established corporates in obtaining ISO accreditations and certification for software and medical devices.
THEY TRUST US
1 Hour FREE
Consultation on your CER
We are excited to announce that we are giving away 10 spots for a one-hour free consultation to help you with your CER.
Our team of medical doctors, biostatisticians, biology and chemist PhDs knows what notified bodies expect, and will prepare your clinical strategy and documentation accordingly.
Dr. Cesare Magri
CEO
contact
Understanding and meeting requirements for medical devices in Europe, the United States and elsewhere can be a challenging task. If you are not certain where to start, which services you need, or if you just wish to ask questions, we are happy to speak with you about your project.
If you need to book a meeting with our experts, please schedule an appoitment