At Sequence Group, we understand the challenges of bringing new medical devices to market and are dedicated to helping our clients navigate the complex and ever-changing landscape of medical device regulation and product development. With years of experience in the industry and a team of experts in regulatory compliance, product design, and software development, we are your one-stop-shop for all things medical device.
New Product Development
Want to Develop a New Device?
Our comprehensive approach to new product development and regulatory consulting takes into account all aspects of the product lifecycle, from concept to market launch. We work closely with our clients to understand their needs and goals, and we bring our expertise and experience to bear in order to ensure that every project is a success.
Whether you are looking to bring a new medical device to market, improve an existing product, or simply need help navigating the regulatory landscape, Sequence Group is here to help. Our services include:
Regulatory planning & strategy
- Regulatory Strategy and Planning: We help our clients develop and implement a strategic plan for navigating the regulatory landscape, from pre-submission activities through to product clearance or approval.
- Regulatory Submission Preparation: Our team of experts is well-versed in preparing comprehensive regulatory submissions, including 510(k)s, IDE applications, and PMA submissions, to help our clients achieve their goals as quickly and efficiently as possible.
- Product Design and Development: Our team of experts in product design, software development, and AI can help you bring your vision to life and ensure that your product is safe, effective, and marketable.
- Quality System and Compliance: We offer a wide range of services to help our clients establish and maintain a robust quality system, including gap assessments, internal audits, and compliance training.
At Sequence Group, we are committed to delivering exceptional service and results to all of our clients. We believe that success is achieved through collaboration and teamwork, and we are always looking for new and innovative ways to help our clients succeed.
