Our Resources
Evidence - Automated Review
Our all-in-one solution for clinical evaluations, state of the art analyses, and post-market literature analyses. Automated. Compliant.
RAQA - Regulatory search engine
Instant access to guidance, recalls, safety notices, and notified body publications. All in one place. Always up to date.
Our Guides - Practical, Sharp, Free
Straight to the point. Regulatory insights you can actually use — no fluff, no filler.
Our Services
Clinical Strategy & Clinical Evaluation
Clinical Evaluation is more than a regulatory obligation it’s a strategic lever. We support you in developing a focused clinical strategy that aligns with EU MDR, speeds up approval, and avoids costly detours. Whether you re planning a literature based route or generating new data, we help you make smart, defensible choices from the start.
Global Market Access for Medical Devices and IVDs
We support manufacturers in bringing their medical devices and IVDs to market in over 20 countries, including the EU (MDR), U.S. (FDA), Japan, Brazil, and Australia. Our team manages the entire regulatory process from strategy to submission—including technical documentation, authority interactions, and audit responses. Whether Class I or Class III, we tailor every step to national and product-specific requirements, ensuring your device is positioned for approval and long term success.
Real World Evidence for Medical Devices
We design and run real world evidence studies PMCF, registries, and observational studies that deliver actionable data. Our focus: generating evidence that satisfies regulators, supports clinical adoption, and aligns with business goals.
Post Market Surveillance – End-to-End Compliance
We manage your entire PMS system from planning to execution to ensure ongoing compliance with MDR and international regulations. Our support covers all key activities, including complaint handling, incident reporting, trend analysis, PSURs, and PMCF integration. We tailor the PMS Plan to your device, define appropriate data sources and methods, and deliver clear, actionable reporting to keep your product on the market and ahead of risk.
Risk Management – Integrated and Compliant
We help you build and maintain a risk management system aligned with ISO 14971 covering the full device lifecycle. From initial risk analysis to continuous file updates, we ensure risks are identified, evaluated, and controlled proactively. Whether as part of your design process or post-market activities, our support keeps your risk documentation audit-ready and defensible.
Biocompatibility
We provide strategic support for biocompatibility assessments in accordance with ISO 10993. From gap analysis to test strategy and lab coordination, we help you demonstrate biological safety efficiently and without overtesting. Our approach ensures your documentation meets regulatory expectations while staying aligned with the device actual risk profile.
What Our Clients Say About us
I had the pleasure to work with Cesare Magri during my time at Radiomics. He and his team were instrumental in helping us setting up our QMS system, giving clear advices and helpful indications to create our documentation, especially related to the Clinical Evaluation process for Medical Device Software. I had the chance to work closely with Cesare, which acted as a mentor for me and my team, guiding us in the compilation of two different Clinical Evaluations files for MDSW under MDD. He also provided keen insight and hands-on explanation on how to better address clinical data collection and presentation, also in the light of the challenging transition towards MDR. I would welcome the chance to work again with Cesare in the future!
I have had the pleasure of collaborating with Cesare on numerous occasions as a senior colleague and reviewer of his work. Cesare has consistently demonstrated a commendable level of independence and proficiency as a Medical Writer for Clinical Evaluation Reports under EU MDR and related documents. His meticulous attention to detail and dedication to producing high-quality work are evident in every project we've worked on together. Cesare's professionalism and expertise make him a valuable asset to any team. I highly recommend him for his exceptional contributions in the field.
Ceasare and his team were great to work with! They bring tremendous Clinical Med Device knowledge and experience to the table and helped us through multiple EU MDR Initiatives. Highly recommended!
Unlock Market Access, Contact Us
Your innovation deserves a smooth path to market. We manage regulatory and market entry challenges for medical devices worldwide.