Digital Health Consulting

Are you developing software that classifies as Software as a Medical Device (SaMD)? Do you need to determine if your software classifies as a medical device or needs validation?

EMMA International’s in-house experts will answer your questions and help advance your software from development to approval. With decades of global experience, we’re here to assist with digital health regulatory requirements worldwide.

Digital Health Timeline

Product Development

Our in-house software engineers can support all your R&D activities and ensure your software development lifecycle meets all global regulatory requirements.

Learn more about product development.

Regulatory Strategy

Our regulatory consults will help you determine the type of submission to file, as well as any exemptions and testing requirements.

Learn more about our regulatory strategies.

Clinical Investigations

Regulatory clearances and approvals dependon successful clinical trials. Trust EMMA International to prepare the entire suite of regulatory documents accurately and on time. Our services extend to study design development, identifying and monitoring clinical sites, generating clinical investigation reports, and other clinical trial activities.

Learn more about clinical investigations.

Regulatory Submissions

Leave the paperwork to EMMA International. We compile and submit all regulatory documents, as well as communicate with regulatory agencies to ensure a seamless submission process for your product.

Learn more about regulatory submissions.

QMS Development

Using EMMA International’s proprietary QMS methodology, CLIC™, we develop and implement QMS systems that are Compliant, Lean, Integrated, and Customizable. An integrated QMS ensures your software development lifecycle and maintenance align with international standards such as IEC 62304, ensuring added compliance and a competitive advantage.

Learn more about CLIC™ QMS Development.

QMS Maintenance

EMMA International’s team of quality and regulatory experts integrate with your team to maintain QMS compliance. We maintain all aspects of your QMS, from CAPAs and supplier activities to regulatory inspections.

Learn more about QMS implementation.

Post-Market Surveillance

Free up time for what’s important: developing products that protect public health. EMMA International takes care of post-market surveillance and vigilance reporting activities. You take care of innovation.

Learn more about post-market compliance.

Ready to learn more about EMMA International’s digital health services? Contact us.

Ready to learn more about working with us?

Digital Health Resources

The Use of AI to Avoid Misdiagnosis

The Use of AI to Avoid Misdiagnosis

The international Banff classification is commonly used by physicians to analyze biopsies of the transplanted kidneys. This is used to diagnose the rejection of kidney transplants; however, this classification has become more complex which leads to variability in its application and misclassification. These misclassifications can lead to physicians failing to modify or incorrectly modify the treatment regimen to protect the patient.
Digital Health

Digital Health

Since the introduction of the term by Seth Frank back in 2000 [1], the idea of digital health has revolutionized many of our current healthcare and global health practices. With roughly 6 billion USD in funding in 2017, the development of digital health technologies and the systems in which they run were appearing at an extremely rapid rate [1,2]. Currently, the FDA categorizes digital health into mobile health, health information technology, wearable devices, telehealth and telemedicine, and personalized medicine [2,3].
The Digitalization of Quality Management Systems

The Digitalization of Quality Management Systems

One blessing that occurred in the recent years is the rapid digitalization of business functions. It’s hard to imagine a time before the use of video calling or instant messaging to reach teammates or clients from across the world almost immediately.

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