SaMD & Digital Health Enabling Digital Health Innovation
Through Safer, Smarter & Compliant Software
Accelerating Digital Health Innovation Through Engineering, Quality & Regulatory Excellence
The future of healthcare is being transformed by intelligent software, connected medical devices, artificial intelligence, cloud technologies, and digital health ecosystems. As Software as a Medical Device (SaMD), Software in a Medical Device (SiMD), and healthcare applications continue to evolve, organizations need solutions that combine innovation with safety, quality, cybersecurity, interoperability, and regulatory compliance.
At SARACA, we provide end-to-end Engineering, Quality, and Regulatory services for SaMD, SiMD, and healthcare applications—from product strategy and requirements through software development, verification and validation, regulatory readiness, commercialization, and post-market lifecycle management.
Our multidisciplinary expertise brings together software engineering, medical device regulations, quality, risk management, cybersecurity, clinical evaluation, AI/ML, and digital health technologies to help organizations develop secure, scalable, compliant, and market-ready solutions.
Whether you are developing standalone medical software, embedded medical device software, AI-enabled healthcare solutions, digital therapeutics, remote patient monitoring platforms, medical imaging solutions, or enterprise healthcare applications, SARACA integrates engineering and compliance throughout the product lifecycle.
Who We Serve
Medical Device Manufacturers
Digital Health Companies
Healthcare Technology Companies
Healthcare Providers
Pharmaceutical & Life Sciences Organizations
Digital Health Solutions We Support
SARACA helps organizations develop and manage safe, secure, compliant, and market-ready digital health solutions.
Software as a Medical Device (SaMD)
Software in a Medical Device (SiMD)
Healthcare Applications
Our Service Offerings
SARACA combines Engineering, Quality, Regulatory, Clinical, Risk, Cybersecurity, and AI/ML expertise across the digital health product lifecycle.
Strategy & Product Engineering
Strategy & Product Engineering
Software Development & Lifecycle
Software Development & Lifecycle
Verification, Validation & Usability
Verification, Validation & Usability
Cybersecurity & Risk
Cybersecurity & Risk
Quality & Regulatory
Quality & Regulatory
Clinical & AI/ML
Clinical & AI/ML
Post-Market & Lifecycle Management
Post-Market & Lifecycle Management
Our Expert Team
At Saraca, we have a team of 50+ medical writers, regulatory affairs professionals, and scientific professionals who have successfully supported the development, registration, and lifecycle management of products. Our expert team has wide experience in pharmaceuticals and comprehensive experience in managing and supporting over 250+ products across a wide spectrum of therapeutic areas. Our team possesses extensive experience in developing high-quality regulatory, scientific, clinical, non-clinical, quality, and pharmacovigilance documentation in accordance with national, international, and regional regulatory requirements. We support pharmaceutical manufacturers, marketing authorization holders (MAHs), contract research organizations (CROs), and healthcare companies in preparing submission-ready documents that meet the requirements of health authorities worldwide.
Our expert team has experience with a diverse range of products, including oncology (anti-cancer), anti-diabetic, gastroenterology products, antibiotics, and other specialty and prescription pharmaceuticals. We support manufacturers and Marketing Authorization Holders across the product lifecycle with regulatory strategy, scientific writing, compliance solutions, and commercialization support to bring products to market efficiently and successfully.
Project Range
Engineers with Domain Experience
Specialists in Global Regulations
Medical Writers
Medical Software Development Lifecycle (SDLC)
SARACA follows a structured, risk-based SDLC aligned with applicable medical device standards and regulatory requirements. Our approach integrates engineering, quality, risk, cybersecurity, usability, and regulatory considerations throughout the software lifecycle.
Strategy & Planning
- Intended Use & Regulatory Classification
- Product & Regulatory Strategy
- Software Safety & Risk Planning
- Development Planning
Requirements & Design
- Software Requirements & Traceability
- System & Software Architecture
- UX/UI & Usability Engineering
- Cybersecurity & Risk Controls
Development
- Embedded, Web, Mobile & Cloud Development
- AI/ML & Connected Health Solutions
- Secure Software Development
- Configuration & SOUP/OTS Management
Verification & Validation
- Unit, Integration & System Testing
- Test Automation & Regression Testing
- Performance, Reliability & Security Testing
- Requirements-to-Test Traceability
Quality & Regulatory
- IEC 62304-Aligned Software Lifecycle
- ISO 13485 & ISO 14971 Alignment
- Usability & Cybersecurity
- Technical Documentation & Design Controls
- Regulatory Readiness & Gap Assessment
Deployment & Commercialization
- Release & Deployment Readiness
- Regulatory Submission Support
- Product Launch & Global Market Readiness
- Production & Maintenance Planning
Post-Market Lifecycle
- Software Maintenance & Updates
- Post-Market Surveillance & Vigilance
- Complaint Handling & CAPA Support
- Cybersecurity Monitoring & Vulnerability Management
- Change Management & Regulatory Impact Assessment
- Continuous Improvement
Standards, Technologies & Regulatory Frameworks
SARACA supports applicable standards, regulations, and technology frameworks based on the product, intended use, risk profile, and target market.
How We Work
Product Planning & Concept
- Define intended use and target users.
- Identify business, clinical, and regulatory objectives.
- Create product backlog and release roadmap.
Regulatory Strategy & Software Classification
- Determine applicable regulations and standards.
- Classify software safety class and regulatory pathway.
- Establish Software QMS and Design Controls.
Software Development (IEC 62304)
- Plan and execute Agile sprints.
- Develop software and perform code reviews.
- Maintain traceability and QMS documentation.
Verification & Validation (V&V)
- Execute unit, integration, system, and acceptance testing.
- Verify requirements and validate software performance.
- Document V&V evidence and manage defects.
Release & Regulatory Documentation
- Conduct release readiness and software approval.
- Prepare technical documentation and lifecycle records.
- Complete RTM, Risk File, and regulatory documentation.
Post-Market Surveillance (PMS) & Maintenance
- Monitor complaints, incidents, and cybersecurity.
- Perform CAPA, change management, and software updates.
- Maintain PMS, PMCF, PSUR, and regulatory compliance.
Continuous Product Improvement
- Review customer feedback and PMS data.
- Prioritize backlog and implement enhancements.
- Continuously improve quality and compliance.
Product Planning & Concept
- Define intended use and target users.
- Identify business, clinical, and regulatory objectives.
- Create product backlog and release roadmap.
Regulatory Strategy & Software Classification
- Determine applicable regulations and standards.
- Classify software safety class and regulatory pathway.
- Establish Software QMS and Design Controls.
Software Development (IEC 62304)
- Plan and execute Agile sprints.
- Develop software and perform code reviews.
- Maintain traceability and QMS documentation.
Verification & Validation (V&V)
- Execute unit, integration, system, and acceptance testing.
- Verify requirements and validate software performance.
- Document V&V evidence and manage defects.
Release & Regulatory Documentation
- Conduct release readiness and software approval.
- Prepare technical documentation and lifecycle records.
- Complete RTM, Risk File, and regulatory documentation.
Post-Market Surveillance (PMS) & Maintenance
- Monitor complaints, incidents, and cybersecurity.
- Perform CAPA, change management, and software updates.
- Maintain PMS, PMCF, PSUR, and regulatory compliance.
Continuous Product Improvement
- Review customer feedback and PMS data.
- Prioritize backlog and implement enhancements.
- Continuously improve quality and compliance.
