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Systems

Design History Folder Develoment

Design History Folder Development

DHS is your trusted partner in navigating the complex landscape of medical device development. Our team can help in the seamless creation and management of Design History Folders (DHF) - the cornerstone of regulatory compliance and product excellence in the healthcare industry. We recognize that each medical device project is unique. That's why we work closely with you to develop a DHF strategy that aligns with your product's specific goals and regulatory demands.

Our goal is to guide you from concept to market success. With a meticulously crafted DHF in hand, you can confidently bring your innovative medical device to patients in need.

Risk Management

Risk Management

DHS is committed to empowering you with the tools and expertise to develop a comprehensive Risk Management File (RMF) that not only complies with stringent FDA and ISO regulations but also instills confidence in your product's safety and efficacy. Our approach ensures that your RMF documentation is thorough, accurate, and well-organized. We leave no stone unturned in identifying, assessing, and mitigating risks associated with your device.

Requirements Analysis

Requirements Analysis

Our seasoned team brings a wealth of experience in requirement analysis and tracing, specializing in the unique demands of the medical device industry. Our analysis process ensures that all requirements, whether functional, design, or regulatory, are thoroughly documented and scrutinized. Whether it is revising the existing requirements drafted by your team or starting fresh, our team can work with you to fully define requirements for your product. We also provide robust traceability matrices that allow you to easily track requirements from User Needs to lower-level requirements throughout the product development lifecycle.

Verification & Validation

Verification & Validation

DHS team of seasoned engineers can provide help with various forms of software verification, meeting requirements of FDA regulations and IEC 62304 standards.

These include requirements-based verification, unit test development and integration test development.

DHS experience with test automation can be instrumental in bringing your solutions to market quicker saving you time and cost.

SOUP Analysis

SOUP Analysis

Addressing Software of Unknown Provenance (SOUP) is a critical aspect of developing safe and effective medical devices. With our expertise in SOUP analysis, we empower you to manage and mitigate the risks associated with third-party software components. We help you identify and address potential vulnerabilities, ensuring that your medical device remains secure and reliable.

Labeling/IFU

Labeling/IFU

DHS offers services to help ensure that your product’s labeling and Instructions for Use (IFU) meet the latest standards set by regulatory authorities such as the FDA, CE Mark, and international agencies. This includes updating your product's current labeling or starting completely from scratch. Our team can help you develop user friendly labeling material that meets the strict standards of regulatory bodies.

CSV/Tool Validation

CSV/Tool Validation

Service provided include tool and method validation activities including Computerized System Validation (CSV).

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