Cutting-edge Biotech
Innovative Solutions for a Better Future
01
Systems & Clinical
We provide comprehensive services throughout the Software Development Life Cycle (SDLC), including the creation of User Needs, System Requirements, and Software Requirements Specifications. Our expertise extends to performing and documenting Software Risk Assessments (SRA) and Failure Mode and Effects Analysis (FMEA), ensuring high-quality and reliable software. We develop detailed Traceability Matrices and evaluate Commercial Off the Shelf (COTS) software/tools. Additionally, we support market release and field training with essential documentation, including New Feature Workflows, Troubleshooting Guides, Field Installation Procedures, and Instructions for Use (IFU).
02
Development
Our services encompass a wide range of expertise, including IEC-62304 based SDLC processes and full tech stack software development. We specialize in embedded development, application layer development, and GUI prototyping for web, mobile, and embedded systems. Our capabilities extend to local and cloud data storage, cloud and server architecture, and wired and wireless communications. We adhere to risk management per ISO 14971 and utilize the V-Model development approach for software safety classes A, B, and C. We are proficient in network protocols, cybersecurity, advanced algorithm development, machine learning, and artificial intelligence. Our services also include unit test development, execution, and the use of DevOps tools and frameworks for CI/CD and automated testing strategies.
03
Verification & Validation
Adventus BioTech offers comprehensive Verification and Validation (V&V) services to ensure the reliability and compliance of your medical device software and hardware throughout the Software Development Life Cycle (SDLC). Our V&V services include leading all Verification and Validation activities and defining the process. We write work instructions, create, and validate software and hardware tools, including COTS tools. We perform formal verification and validation, conduct various qualifications (IQ, OQ, PQ), and execute thorough testing. We also lead third-party penetration testing for cybersecurity and develop test automation frameworks. Our planning and documentation services cover the creation of V&V plans, regression analysis, test strategies, and extensive reporting. Trust Adventus BioTech for your V&V needs to ensure your medical devices meet the highest standards of quality and compliance.
04
Quality & Regulatory
Adventus BioTech offers comprehensive Quality and Regulatory Services, including QMS development, SOP alignment with international standards, regulatory submissions, quality control, and audits to ensure compliance and product quality. Our expertise ensures your medical devices meet global standards and regulatory requirements. Trust us for all your Quality and Regulatory needs.
Streamlined Processes
How Our Services Work
Consultation
Initial consultation to understand client needs and expectations
Analysis
In-depth analysis and evaluation of requirements and objectives
Implementation
Timely and efficient implementation of tailored solutions
Ready to Revolutionize Healthcare?
Contact us today to explore how our biotech solutions can empower your organization and improve patient care.