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Develop Fast;
Stay Compliant

Ketryx is the first and only connected lifecycle management software for MedTech that unifies quality and R&D efforts to deliver safer, more innovative software up to 2-3x faster.

Ketryx for Start-ups

Our team has helped to successfully scale many start-up offerings. We’re keenly aware of the competitive challenges you’re facing and make it easier to bring your innovations to life with some of the following special considerations.

We grow as you grow

Onboarding is as simple as connecting Ketryx to your current development tools and assigning teams by project and authority. Manage requirements individually or as a group using agile development processes. The Ketryx compliant-by-design approach includes pre-built guardrails to ensure IEC 62304 compliance throughout.

Achieve Time-to-value in hours rather than weeks or months.

Special pricing/support designed for start-ups

Our monthly pricing and flexible contracts make it easy for you to get started. Ketryx overlays your existing tools and workflows – simply point it at your source code and you’ll be up and running in minutes with FDA-ready documentation automatically generated at all stages. Our expert support team is always available to ensure your success.

Focus on product impact; let us manage the regulatory burden

Ketryx offers predefined, FDA-ready templates and guidance for IEC 62304, ISO 14971, CFR 21 Part 11 built into our software with input from former FDA talent. Instead of worrying about documentation and regulatory hurdles, you can focus on building life-saving products and improving patient outcomes.

Stay on top of new regulatory guidance

As new guidance is issued on critical areas such as security, AI, and ML, we make it easy for you to stay ahead of new requirements. Our expert team continuously releases updates that anticipate new requirements with built-in intelligence.

Streamline documentation with actionable reporting

Generate an FDA-ready Software Bill of Materials (SBOM) directly from your source code and preferred tools in minutes

Comply with regulations around COTS, SOUP, and Off-the-shelf Software (OTS), and Open Source, like IEC 62304/GAMP 5 and CFR21 Part 11

Customized monitoring triggers alerts to ensure you’re using the latest and most secure versions of each software component

Gain peace of mind by detecting and rapidly mitigating security issues before they affect device performance

Easily identify and prioritize risk and associated dependencies. Quickly isolate problematic software applications and versions when known vulnerabilities are discovered.

Reduce time/resources spent on dependency management

Track tens of thousands of Open Source dependencies across multiple teams and existing quality, development, and lifecycle systems to ensure you meet critical development milestones

Leverage the speed advantages from off-the-shelf software without compromising safety

Gain peace of mind that you can safely leverage off-the-shelf software components while focusing your resources on developing life-saving patient solutions


Are You Building Medical Software?

Ketryx is the first and only connected lifecycle management software designed to enable MedTechs to take advantage of Cloud-based tools while maintaining FDA, cGMP, and ISO compliance