Essential security tailored for startups or budget-conscious MDMs prioritizing simplicity and affordability.
Enhanced support for MDMs encountering growth obstacles and navigating regulatory challenges.
Premium support for MDMs prioritizing innovation, collaboration, and regulatory excellence.
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10 products
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The Accelerator bundle is ideal for startups and emerging companies in the medical device sector, as well as established manufacturers seeking cost-effective foundational cybersecurity and regulatory support. This bundle offers essential tools and templates to help you achieve FDA compliance efficiently.
The Standard bundle is ideal for scaling your operations and managing regulatory complexities. It’s also suited for organizations that have encountered setbacks, such as FDA hold letters, and need additional support to ensure successful submissions.
The Premium bundle is ideal for developing highly innovative, connected, and/or wireless medical devices that require specialized cybersecurity measures and regulatory support. This option will offer the most benefits if you have a diverse product portfolio with devices in high-risk categories. It’s also suited for those who prioritize proactive cybersecurity and compliance management to maintain customer trust.
Our SBOM vulnerability solution, Helm, can be combined with MedISAO membership to assist medical device manufacturers in complying with the FDA’s enforcement exemption under Section VII.B of the
FDA Postmarket Guidance(Dec. 2016) and to support them in meeting the criteria for active participation in an ISAO, as defined in Section IX of the same guidance:
Yes, you can upgrade your bundle as your cybersecurity maturity profile evolves. Our bundling strategy is designed to support your growth, offering increasingly comprehensive services as you progress from the Accelerator to the Standard bundle, or from the Standard to the Premium bundle.
We recognize that your needs are unique. If our predefined bundles do not perfectly align with your requirements, we encourage you to contact us. We will work with you to tailor a solution that fits your specific needs and challenges.
Create your own by picking any combination of the above products and services.
Or, kickstart the conversation by completing our maturity assessment.
Our FDA experts are looking forward to talking with you.