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.
Regulatory Strategy
Our regulatory consults will help you determine the type of submission to file, as well as any exemptions and testing requirements.
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.
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.
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.
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.
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.
Ready to learn more about working with us?
Digital Health Resources
