Complizen is an AI-powered FDA compliance workspace designed for medical device teams and consultants. It brings together FDA guidance, 510(k) predicates, product codes, adverse events, recalls, and tests and standards in one place. Instead of spending hours searching across multiple FDA databases, you can ask questions, draft strategies, and access cited, defensible sources in minutes. This helps regulatory professionals save time, improve accuracy, and move their devices to market faster with confidence.

Complizen has two plans, Free and Plus. Free is ideal for startups and individuals exploring AI-powered FDA compliance. Plus unlocks unlimited usage, team collaboration, audit trails, and full export capabilities for regulatory documents and strategy files.

Plus is priced per seat. Choose monthly or annual billing. Annual plans reduce the per-seat cost and are best for teams that plan to use Complizen every day across multiple devices and projects.

Yes. Every user who collaborates in your workspace needs a seat. You can add or remove seats at any time. Seat changes take effect on the next billing cycle unless otherwise stated.

Complizen already offers a Free plan that’s especially well-suited for early-stage startups, since most young companies are focused on bringing a single device to market. The Free plan provides everything needed to explore our AI-powered FDA compliance tools without cost. Teams that require multi-seat collaboration, unlimited device profiles, or advanced export and governance features can upgrade to Plus at any time. For consulting firms, academic groups, and scaling startups, we also provide annual discounts and tailored promotions—contact our team for details.

Yes. You can upgrade, downgrade, or cancel at any time. Changes apply at the next billing cycle. Cancellations keep access through the end of the paid period.

Yes. Complizen uses encryption in transit and at rest, role-based access controls, and private AI. Customer data is not used to train foundation models. Version history and audit trails in Plus improve governance for regulated teams.

Yes. Consulting firms use Plus to standardize research, reduce time spent on guidance pulls and predicate reviews, and increase client capacity. Multi-seat workspaces, audit trails, and exports make it simple to collaborate and deliver defensible work.

Complizen focuses on U.S. FDA medical devices today. If you need other markets, tell us which jurisdictions matter most so we can prioritize our roadmap.

To get started with Complizen, simply schedule a demo with our team. In the demo, we’ll walk you through how the platform accelerates FDA compliance workflows and answer any questions specific to your devices or processes. After the session, you’ll receive access to the platform—either on the Free plan or Plus—so you can begin building strategies, exploring FDA data, and collaborating with your team.