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 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.
HIPAA and GDPR’s impact on Medical Devices

HIPAA and GDPR’s impact on Medical Devices

The European Union’s General Data Protection Regulation (GDPR), which was put into effect on May 25, 2018, is often considered to be one of world’s toughest laws when it comes to privacy and security. The regulations lay down privacy and security standards, imposing obligations on any/ all organizations having an impact on the people of EU, whether related to targeting or collecting data.
New Imaging Drug for Ovarian Cancer

New Imaging Drug for Ovarian Cancer

In November of 2021, the Food and Drug Administration (FDA) approved Cytalux. Cytalux is a new imaging drug intended to assist surgeons with the identification of ovarian cancer lesions1. This new drug was designed to assist in locating additional ovarian cancer tissues that can be...

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