Decus can help your company at all stages of the medical device lifecycle.
We have the breadth and experience to successfully get medical devices into the marketplace.
Decus by the numbers
We reviewed the work we’ve done for our 100+ clients over the years and found that 80% are start-ups.
The most common types of projects we work on are:
62% of our clients
requested help with:
- Regulatory consulting
- Write parts of or audit a Quality System
38% of our clients
needed help with:
- Develop Design History File/Device Master Record
25% of our clients
hired us to:
- Develop or review 510(k) submissions
- Set up complete Quality System
- Conduct studies (animal, clinical or usability)
- Provide study data management
12% of our clients
selected us to:
- Submit/manage pre-submission meeting requests to FDA
- Develop Technical Files (CE Mark submission)
The quality of our work is reflected in the number of repeat clients we have and their willingness to refer us to new clients. See our Testimonials page for what our clients have to say about us.
Decus is set apart by team members who have advanced degrees in bioengineering and experience in the medical device industry. Learn more at our Team page.