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

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

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.