Regulatory

We understand the complications and difficulties of regulatory laws and the seemingly endless tide of documentation and forms. However, Whitman Designs has the experience and capabilities to ensure that your project meets all necessary requirements so that you can have a successful launch and a long and prosperous product life. We are intimately familiar with the entirety of Title 21 CFR Subchapter H - the section of 21 CFR that pertains to medical devices in the United States - as well as the regulations set forth by ISO 13485. We have our own internal quality system for all projects that upholds and ensures the highest quality possible. However, if your project exists in a regulated space and requires that we follow your internal documentation, we will work with you to accommodate this provision and will operate and perform all functions according to your quality system. When it comes to device manufacturing, we maintain relationships with many organizations and know who has the necessary certifications for regulated device production allowing us to select the right vendors quickly.

We also love to help new companies establish their quality system requirements and management systems (QSRs/QMS) and the 510k process.