MedTech
Faster, safer and remaining compliant
Tailored, integrated regulatory, clinical, and compliance solutions for the medical device and diagnostics industry.
KEY FIGURES
200+
Innovative device technologies
30%
Studies for medical devices
100+
CE mark, FDA 510(k) & PMA related activities
Technology savvy
We cover a full spectrum of innovative and complex integrated device technologies, including combination products, medical devices, IVDs/CDx, and digital health technologies.
Tailored, integrated solutions
From regulatory strategy to medical device clinical investigation management and post-market surveillance & vigilance activity, we provide tailored, integrated regulatory, clinical, and quality compliance solutions.
FAQs
Is my software a medical device?
To determine if your software qualifies as a medical device, consider the following points:
Intended Use, Regulatory Definitions, Functional Claims, Risk and Impact.
1. Intended Use
Regulators assess whether your software is designed to diagnose, prevent, monitor, treat, or alleviate a medical condition.
2. Regulatory Definitions
Different regulatory bodies have specific definitions for medical devices. Reviewing their criteria is essential to determine compliance requirements for your software.
3. Functional Claims
If your software claims to analyze, interpret, or provide recommendations for medical conditions, it is more likely to be considered a medical device. However, general wellness applications that do not impact diagnosis or treatment may not fall under this category.
4. Risk and Impact
Regulators evaluate the potential risk to patients if the software malfunctions or provides inaccurate results.
Useful article:
read more
Should I need a prospective clinical trial for the CE mark notification?
While a prospective clinical trial is not always mandatory, it is crucial to evaluate the specific context and requirements for your device. Consulting with a regulatory expert or a Notified Body is recommended for a definitive answer.
Related Glossary
Questions? Get the answers from our expert team
No two product development paths are the same. Talk to our experts about your development challenges and we will provide you actionable recommendations.