Development for Healthcare & Pharma
Specialized software development for healthcare and pharmaceutical industries. ISO 13485 certified with deep expertise in FDA regulations, HIPAA compliance, and medical device software development.
Healthcare & Pharma Expertise
Healthcare and pharmaceutical software development requires the highest standards of quality, safety, and regulatory compliance. VNcent is ISO 13485 certified, demonstrating our commitment to medical device quality management and our expertise in developing software for healthcare applications.
Our team has extensive experience developing software for medical devices, electronic health records (EHR), clinical trial management systems, pharmaceutical manufacturing, and healthcare data analytics. We understand the critical importance of patient safety, data privacy, and regulatory compliance in healthcare technology.
From FDA-regulated medical devices to HIPAA-compliant healthcare applications, we deliver software solutions that meet the stringent requirements of healthcare and pharmaceutical industries while enabling innovation and improving patient outcomes.
Certifications & Compliance
ISO 13485 Certified
Certified for medical device quality management systems. Our processes and procedures meet the highest standards for medical device software development.
FDA Regulations
Expertise in 21 CFR Part 11 (electronic records), 21 CFR Part 820 (quality system regulation), and medical device software validation requirements.
HIPAA Compliance
Full compliance with Health Insurance Portability and Accountability Act requirements for protected health information (PHI) handling, storage, and transmission.
Additional Standards
Experience with IEC 62304 (medical device software), GxP guidelines, and other healthcare-specific regulatory requirements.
Healthcare Solutions
Medical Device Software
Development of software for medical devices including diagnostic equipment, monitoring systems, therapeutic devices, and medical imaging software. Full FDA compliance and validation.
EHR/EMR Systems
Electronic health record and electronic medical record systems with HIPAA compliance, interoperability standards (HL7, FHIR), and secure patient data management.
Clinical Trial Management
Clinical trial management systems, electronic data capture (EDC), and regulatory submission software for pharmaceutical research and development.
Healthcare Analytics
Healthcare data analytics platforms for population health management, clinical decision support, and healthcare outcomes analysis with HIPAA-compliant data handling.
Healthcare Development Process
Our healthcare development process is designed to ensure regulatory compliance, patient safety, and software quality from the very beginning:
- Regulatory Planning: Early identification of applicable regulations and compliance requirements to guide design decisions.
- Risk Management: Comprehensive risk analysis and mitigation strategies following ISO 14971 for medical devices.
- Software Validation: Rigorous validation protocols including design validation, software testing, and regulatory documentation.
- Quality Assurance: ISO 13485 compliant quality management system with traceability, change control, and audit readiness.
Ready to Build Healthcare Software?
Contact our healthcare development team to discuss your medical device or healthcare application needs.