Knowledge Center

Struggling with Compliance for Your Digital Health Solution?

Is Your Software a Wellness Device or a Medical Device?

 

Navigating the fine line between wellness devices and medical devices can feel overwhelming. Whether you're working on Software as a Medical Device (SaMD) or Artificial Intelligence as a Medical Device (ALaMD), the pressure to meet stringent regulatory requirements while innovating is real.

But here’s the good news: you don’t have to do it alone!

 

What You Need to Know About SaMD and ALaMD

The International Medical Device Regulators Forum (IMDRF) defines SaMD as software used for medical purposes that functions independently of a hardware medical device.

If your software processes data for diagnosis, monitoring, or therapeutic purposes and operates without being embedded in hardware, it’s likely a SaMD. However:

• Software designed purely for general healthcare or lifestyle purposes doesn’t fall under this category.

This distinction might seem straightforward, but the evolving regulatory landscape can make it difficult to navigate.

 

The Challenges You Face

Are these keeping you up at night?

• Uncertainty about classification: Is your innovation SaMD, ALaMD, or just a wellness app?
• Regulatory headaches: Are you compliant with EU MDR, UKCA, or US FDA standards?
• Skyrocketing costs: Are you worried about how compliance might eat into your budget?
• Cybersecurity threats: Is your innovation secure from risks that could impact your end-users?

 

Med-Di-Dia Has You Covered

Appoint Med-Di-Dia as Your Regulatory Risk Partner to simplify your compliance journey. Whether you're a startup, SME, or established MedTech company, we have the expertise to help you stay compliant and scale your innovations.

 

Here’s how we’ll help:

• SaMD and ALaMD Compliance: From regulatory classification to submissions in the EU, UK, and USA.
• Cybersecurity Risk Management: Don’t let cyber threats derail your product. We’ll safeguard your innovation.
• IoMT Risk Solutions: Developing connected devices? We’ll manage risk across your entire ecosystem.
• Standards and Regulations: ISO 14971:2019, good software practices, technical file submissions, and more.
• Data Protection: Ensure compliance with personal data laws for patient information on digital platforms.

We’re not just a service provider but your partners in regulatory success.

 

BLACK FRIDAY & CYBER MONDAY SPECIAL OFFER!

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We’re offering a 30-minute, no-obligation consultation call for digital health innovators for a limited time. This is your chance to discuss your challenges with our experts and get tailored guidance at no cost.

🚀 Let us help you:

• Classify your software correctly.
• Identify the most efficient regulatory pathways.
• Secure your innovation against cybersecurity threats.
• Reduce compliance costs while increasing efficiency.

 

Claim Your FREE Call Now!

📧 Email us at mdd@mddltd.com
🌐 Fill out the form on our Contact Page

⏳ Offer valid until 3 December 2024! Don’t miss out.

 

 

Innovate. Comply. Succeed.

Let Med-Di-Dia take on the regulatory burden so you can focus on what you do best—creating digital health solutions that transform lives.

 

📖 Learn more about our services here: Digital Health Services.

This is your moment. Let Med-Di-Dia be the regulatory guardian of your digital health galaxy!