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Empowering Health Systems With Cutting-Edge Technology

Welcome to Digital Health Solutions. Our innovative solutions empower providers and improve patient outcomes, setting new standards for excellence in the industry

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Product Development

Class II & III​ Medical Device

Connected Embedded Devices

Product Ideation

End-to-End

Product Development ​

Design History File Remediation ​

Electrical Design

Industrial Design/DFM ​

Supply Chain ​

Engineering Project Management

Backend Developer

Software

Firmware

Mobile App

Web Development

IoT

Machine Learning/AI

EHR Integration

SaMD

IEC 62304

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Cybersecurity

Cybersecurity Remediation

Secure Product Development

Threat Modeling​​

Security Risk Assessment
SBOM
Penetration Testing
Vulnerability Scanning​

Post Market Surveillance

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Systems

Design History Folder Development

Risk Management
Requirements Analysis​

Verification and Validation​

SOUP Analysis
Labeling/IFU
CSV/Tool Validation

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QA/RA

FDA & CE Compliance
QMS Design & Support
Quality Assurance
Regulatory Services
Standard Operating Procedure Development​

ISO 13485 Certification

Why Choose

Digital Health Solutions

Digital Health Solutions success stems from our commitment to delivering high-quality, cost-effective services promptly. We leverage a blend of engineering talent comprising software developers and testers based in Boston, MA, and India. This combination ensures a balance of exceptional competency and affordability for end-to-end software development consulting.

We welcome the chance to engage with you, understand your requirements, and potentially offer tailored solutions for your product or software development needs.

Digital Health Solutions

Why Choose

Digital Health Solutions

"DHS has proven to be an indispensable partner in our journey towards FDA approval. Their hands-on, well organized, and adaptable approach has streamlined our documentation process, and their subject matter expertise has proved to be invaluable. DHS’s proficiency in their field has greatly contributed to our success. We are very pleased with the results they’ve delivered."

Mike Sampson

Chief Commercial Officer, NanoDx

"DHS was invaluable to our team in the development of the DHF for our SaMD. The DHS technical team provided guidance in all elements of design controls, including serving as independent reviewer in code review design reviews. We found the DHS team to be knowledgeable and easy to work with, along all levels of experience in our organization. That went from new-to-medtech commercial software developers to experienced (though less so in SaMD) medical device professionals. Another major factor in my recommendation of DHS is their command of the ever-changing FDA Guidances on software, cybersecurity in particular."

Matt Garrtiy

Director of Quality, Riva Health

"Neuroglee had the pleasure of working with DHS on a business-critical project aimed at achieving ISO 13485 certification. DHS played a crucial role in setting up our eQMS and implementing effective design controls, which streamlined our development processes. Their extensive knowledge of IEC 62304 compliance requirements ensured our software met the highest industry standards for safety and effectiveness.
 
Additionally, their guidance in developing the Design History Folder and their expertise in quality and regulatory processes were instrumental in our successful certification. We highly recommend DHS for any company seeking to navigate regulatory compliance complexities and achieve excellence in their quality management systems."

Aniket Singh Rajput

Founder & CEO, Neuroglee Health

Mike Sampson

Chief Commercial Officer, Nano Dx

"DHS has proven to be an indispensable partner in our journey towards FDA approval. Their hands-on, well organized, and adaptable approach has streamlined our documentation process, and their subject matter expertise has proved to be invaluable. DHS’s proficiency in their field has greatly contributed to our success. We are very pleased with the results they’ve delivered."

Matt Garrtiy

Director of Quality, Riva Health

"DHS was invaluable to our team in the development of the DHF for our SaMD. The DHS technical team provided guidance in all elements of design controls, including serving as independent reviewer in code review design reviews. We found the DHS team to be knowledgeable and easy to work with, along all levels of experience in our organization. That went from new-to-medtech commercial software developers to experienced (though less so in SaMD) medical device professionals. Another major factor in my recommendation of DHS is their command of the ever-changing FDA Guidances on software, cybersecurity in particular."

Aniket Singh Rajput

Founder & CEO, Neuroglee Health

"Neuroglee had the pleasure of working with DHS on a business-critical project aimed at achieving ISO 13485 certification. DHS played a crucial role in setting up our eQMS and implementing effective design controls, which streamlined our development processes. Their extensive knowledge of IEC 62304 compliance requirements ensured our software met the highest industry standards for safety and effectiveness.
 
Additionally, their guidance in developing the Design History Folder and their expertise in quality and regulatory processes were instrumental in our successful certification. We highly recommend DHS for any company seeking to navigate regulatory compliance complexities and achieve excellence in their quality management systems."
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