Ensure Full Compliance for Your Medical Device Software
Navigating the regulatory landscape for Medical Device Software can be challenging, especially with varying requirements across different markets. From safety classification, clinical evaluation to risk management and post-market obligations, staying compliant is critical for your software’s success.
GBA Key2Compliance offer expert guidance in ensuring your software meets all necessary regulations, whether you’re targeting the EU, US, or global markets. Let our team guide you through the complexities and help you avoid costly mistakes on your path to compliance.
Your Software Could Be a Medical Device – Find Out More
Curious if your software qualifies as a medical device? Watch this quick video to discover what compliance means for your project and the essential steps to navigate MDR and IVDR requirements. Don’t miss out—understanding the rules could make all the difference for your software.
Whether you’re launching new software or updating legacy products, we offer the tools and support to navigate complex regulations and succeed in the market.
Jumpstart Your Road to Compliance!
Book a 30 Minutes Consultation
Discuss your product, challenges and next steps with our experts. In your personalized session, we’ll help you:
- Discuss if your software qualifies as a medical device.
- Explore the classifications that may apply to your product.
- Outline the necessary steps for MDR approval.
Plus, discuss any specific challenges or stages in your development process. Tailored to your needs, this session is your first step towards compliance.
Price: Free
Get Started!
Test your software with our checklist to determine what regualtions may apply
Understanding Medical Device Software Compliance
Medical Device Software faces unique regulatory challenges, requiring a robust approach to ensure it meets all relevant standards and performs safely in a healthcare environment.
The key reasons include:
Software Safety and Performance:
Medical Device Software (MDSW) regulations emphasize strict requirements for software validation, risk management, and safety classification. Ensuring your software meets these standards is critical to maintaining patient safety and system reliability..
Traceability and Documentation:
Regulatory compliance demands detailed technical documentation and traceability of software versions. This includes maintaining up-to-date records of development processes, risk assessments, and performance testing, ensuring the software remains safe throughout its lifecycle.
Global Regulatory Alignment:
Medical Device Software (MDSW) compliance extends beyond a single region, requiring adherence to multiple regulatory frameworks, such as the MDR in Europe and FDA guidelines in the US. Keeping up with these regulations ensures market access and long-term product success.
Avoid Costly Mistakes in Medical Device Software Compliance – Download Our Essential Guide
Are you ready to tackle regulatory compliance for your Medical Device Software?
Our guide, Common Pitfalls for MDSW Regulatory Compliance, offers practical insights to help you avoid costly mistakes.
Learn more about classifying your software correctly, managing risks effectively, and keeping up with evolving regulations.
Download the guide now to streamline your path to market success!
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