FDA & CE Compliance
DHS is here to help guide you through the path from idea conception all the way to regulatory submission. Our team of experts will work with your company to ensure your product is compliant with all applicable FDA guidances and CE requirements. We can help identify a regulatory strategy that fits the unique needs of your product and ensure a smooth submission pathway.
QMS Design & Support
Building a robust Quality Management System (QMS) is a key to success in the highly regulated medical device sector. DHS can help your company in creating, implementing, and maintaining a QMS that ensures compliance, quality, and innovation. We can help companies start their QMS with our industry partners specifically focused on electronic QMS (eQMS) or manage through a paper-based system to best fit the needs of the company. We ensure that your QMS solution complies with the latest directives and standards established by authorities such as the FDA, ISO, and more. Our team provides support in the implementation phase, ensuring a smooth transition.
DHS offers a wide range of services to support any Quality Assurance needs your company may have. We maintain a large team comprised of skilled test engineers who can help develop and execute verification testing. Our verification team can also manage the large documentation burden that comes with Quality Assurance. Our approach is adaptable to align with your specific design and development needs in proportion to the risk level of the device and regulatory strategy.
The path to market for medical device products, and more specifically software as a medical device, in the healthcare industry can be complex. DHS is here to help guide your company and team seamlessly through the regulatory landscape, ensuring compliance, approvals, and market access for your innovative solutions.
Our team has an in-depth knowledge of preparing technical files to support submissions for 510(k), Letter to File, Clinical Decision Support Tools, De Novo products, and systems needing ISO 13485 compliance.
Standard Operating Procedure Development
DHS is experienced in developing SOPs tailored to the medical device field. We are skilled in drafting SOPs covering a range of topics including design controls, software development life cycle, cybersecurity, and IT policies. Our company will work with your team to develop SOPs to govern the development and production of medical devices applicable to your unique company's needs.
ISO 13485 Certification
If your company has a goal of obtaining an ISO 13485 Certification (Medical Device - Quality Management System - Requirements for regulatory purposes), DHS is here to help. Our team can help align your QMS to the latest standards and guidances to successfully obtain an ISO 13485 Certification from an accredited certification company. We help provide a review of the current QMS and assess the work that needs to be done to be compliant with the standard. DHS will work closely with your team to ensure that all gaps in the current QMS are closed, and the necessary employees are trained on applicable procedures for their roles.