Class II & Class III Medical Devices
Design, development, and testing of Class II and Class III Medical Devices for submission to FDA and other regulatory bodies. Full support of activities from the ideation stage to validation to generate a complete Design History File.
Connected Embedded Devices
Design and development of connected embedded devices for medical applications. This includes the documentation and testing of the design. Specialized in devices supporting connectivity, data acquisition and processing, API integration, and always designed with cybersecurity in mind.
DHS team of US based experts is available to work with your business, regulatory and product development teams to help develop your product roadmap strategy.
We can help provide rapid prototype development that can significantly reduce technology risks and allow your team to refine the product strategy. The reusable code developed at informal stage of product development would later be brought under design controls to meet your quality system and regulatory needs.
End-to-end Product Development
DHS has clients that possess expertise in their core competency but needed to partner with an organization like Digital Health Solutions that has world class expertise in developing software under design controls that is compliant with all regulatory requirements.
Digital Health Solutions will become a partner with your business and internal product development team to take full ownership of software development responsibilities and can also help augment an existing software development team.
Call DHS and we can discuss specific strategies to customize development solutions for your project.
Design History File Remediation
Our experts at DHS can review a product's Design History File (DHF) or feedback provided by an FDA review of a product to produce a comprehensive report identifying any deficiencies, gaps and remediations for the product seeking regulatory approval.
Design, development, and testing of printed circuit boards (PCBs) used in medical device products. Services offered include designing, technical reviews, documentation, and testing of new or existing electrical designs. All solutions are designed with manufacturability, compliance, and sustainability in mind.
Industrial Design & Design for Manufacturability
Specialize in mockups and full industrial designs including material selection, design simplification, standardization, design for testability, reduction in waste, and tolerance allowance considerations.
Supply chain management offerings include developing a flexible and cost-effective approach to managing supply chain operations. This enables businesses to optimize their supply chain, reduce costs, mitigate risks, and improve overall efficiency. DHS can provide supply chain services or solutions adaptable to today's rapidly changing and increasingly complex global business environment.
Engineering Project Management
Engineering management offerings adjusted to the specific needs of the company or project. Offer capabilities in planning, budgeting, project schedules, resource management, project risk mitigations, and scalability of solutions.