What services do you offer for medical device development?
We offer a range of services including discovery and concept development, product development, design verification, validation, and writing and submission of device applications. In addition, we provide support for compliance with U.S. and international regulatory standards, as well as technical writing and regulatory agency meeting support.
How do you assist clients who desire compliance with U.S. and international regulatory standards?
Our team has extensive knowledge and experience in navigating the regulatory landscape for medical devices. We work closely with our clients to design a development program following regulatory standards and guidelines, and to proactively provide engaged strategic regulatory support throughout development, strategic writing, submission, and post submission interactions with regulatory agencies.
What is your experience in the medical device industry?
We have a team of experts with decades of combined experience in the medical device industry. We have worked on a wide range of products and have a deep understanding of the development process and regulatory requirements.
Can you help with technical writing for my medical device?
Yes, our team is experienced in technical writing for medical devices. We can help with everything from creating design control documents to writing IFU’s and regulatory submissions.
How do you work with clients to plan and coordinate projects?
We work closely with our clients to understand their goals and needs, and develop a project plan that balances budget, timeline, and quality while considering potential project risks. We also proactively communicate and collaborate with our clients throughout the development project.