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Elite Partner

Estenda Solutions

AI and custom software solutions for MedTech and Life Sciences

11-50 employees
Verified
3 Certs

About Estenda Solutions

Estenda Solutions is a healthcare technology services provider specializing in custom software development, AI/ML solutions, and data analytics for the MedTech, Life Sciences, and healthcare provider sectors. With 22 years of experience serving healthcare clients, the company has completed hundreds of projects focused on improving patient care, clinical outcomes, and operational efficiency.

The firm maintains ISO 13485 certification and operates as a registered Pennsylvania small business with services available through GSA Schedule 70. Their technical capabilities span AI-powered diagnostics, predictive modeling, HL7/FHIR integration, telehealth platforms, and clinical trial data management. Estenda's approach emphasizes regulatory compliance, with expertise in HIPAA, HITECH, GDPR, and FDA requirements.

Notable implementations include diabetic retinopathy screening systems for Indian Health Service facilities and comprehensive diabetes management programs integrating telehealth with EMR systems. The company has contributed to peer-reviewed clinical research publications and received multiple patents for solutions developed in collaboration with clients.

Best For

MedTech companies and Life Sciences organizations requiring custom software development with strong regulatory compliance credentials. Organizations pursuing AI/ML initiatives for clinical decision support, diagnostics, or research acceleration will find relevant expertise, particularly those working with medical devices or conducting clinical trials requiring HIPAA-compliant data platforms.

Key Strengths

  • 22 years of focused healthcare technology experience with ISO 13485 certification demonstrating quality management for medical devices
  • Documented expertise in AI/ML applications for healthcare including diabetic retinopathy screening and predictive analytics platforms
  • Proven integration capabilities with HL7, FHIR standards and EMR systems as evidenced by implemented telehealth solutions
  • Track record of contributing to peer-reviewed clinical research publications and patent-generating innovations
  • GSA Schedule 70 availability providing streamlined procurement for government healthcare agencies
  • 100% client satisfaction rating based on testimonials emphasizing responsiveness and customized approach

Why Choose Estenda Solutions

Select Estenda when you need a healthcare-specialized technology partner with deep regulatory knowledge and proven AI/ML capabilities. Their ISO 13485 certification and 22-year healthcare track record make them particularly suitable for medical device companies requiring compliant custom software or Life Sciences organizations building clinical trial platforms.

Expect a consultative engagement style with emphasis on understanding nuanced requirements. Client testimonials consistently highlight responsiveness and solution-focused collaboration, suggesting a partnership approach rather than transactional delivery model.

Healthcare Focus

Estenda serves exclusively healthcare, MedTech, and Life Sciences clients, with their entire service portfolio designed around healthcare-specific requirements. The company's ISO 13485 certification specifically addresses medical device quality management, while their documented experience includes HIPAA, HITECH, GDPR, and FDA compliance frameworks.

Their healthcare vertical expertise spans provider organizations (diabetes management, retinopathy screening), medical device companies (real-world performance tracking), and research institutions (clinical trial platforms). Case studies demonstrate implementations for federally qualified health centers, Indian Health Service facilities, and academic medical centers including Joslin Diabetes Center.

Ideal Client Profile

Medical device manufacturers requiring FDA-compliant software development, pharmaceutical companies building clinical trial data platforms, or healthcare providers implementing AI-powered diagnostic tools. Organizations that value deep healthcare domain expertise and require partners who understand both technical implementation and regulatory pathways. Best suited for clients seeking collaborative, customized solutions rather than templated products.

Specializations

AI/ML for healthcare FHIR integration HL7 standards Custom medical device software Clinical trial data platforms Diabetic retinopathy screening Telehealth solutions

Client Types

Medical Devices Pharma Digital Health Healthcare Startups Hospitals

Why Choose Estenda Solutions?

  • 11-50 team members
  • 3 certifications verified
  • Elite Partner on Curatrix
  • Verified on Curatrix

Quick Facts

Company Size
11-50 employees

Certifications

hipaa fda 21 cfr part 820 iso

Profile last updated: Jan 24, 2026

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