Customer Story

Genetesis Leverages Ignyte Platform to clear FDA and Cyber Compliance Objectives






FDA and Cyber Compliance Objectives


Medical Equipment Manufacturing

The Problem

Genetesis is a medical technology company with ten years of industry experience, encompassing device and software components. The increasing importance of cybersecurity in the medical device sector, driven by regulatory concerns from the FDA and the proliferation of consumer-centric devices handling sensitive information, prompted a heightened focus on security in a landscape where 90% of healthcare organizations have experienced at least one cyberattack due to inadequate protections.

“Ease of use and the ability to manage our ISO 27001 certification, CAPA, HIPAA Compliance efforts, supplier risk, and asset management. The platform helps us proactively manage risk & compliance operations, coupled with a knowledgeable and responsive support team. The automated cross mappings between the current work and future initiatives such as FedRAMP, CMMC, and similar frameworks are helpful.¬† The principles are very knowledgeable about cyber operations and governance, risk, and compliance. We would highly recommend that others take a close look at their product offering.”

Emmanuel Setegn

Chief Technology Officer

The Solution

In pursuit of FDA and cybersecurity compliance objectives, Genetesis recognized the critical need to ensure the safety, security, and privacy of patient data. The urgency stemmed from the realization that many healthcare organizations lacked proper safeguards, leaving data vulnerable. Genetesis is committed to a patient-centric approach and acknowledges the profound impact of technology on people’s lives. That’s why, for over a year, we’ve been partnering with Ignyte. As a small business, we place great value on relationships and found Ignyte’s approach aligning with our needs. They have a track record of supporting businesses, even locally, and their commitment to understanding short-term requirements while providing scalability is impressive. The next crucial step is technical competence. Partnering with a company like Ignyte, which brings a cybersecurity mindset to projects from the outset, ensures we are well-prepared to overcome potential challenges on the journey.


Cost avoided in potential FDA audit failure


Success rate in achieving emerging FDA 510K Cyber compliance


Operational efficiencies on control responses

The Result

Future-Ready Compliance Alignment

The product’s automated cross-mappings were a game-changer for Genetesis. They effortlessly aligned current work with future initiatives like FedRAMP, CMMC, and similar frameworks. This feature ensured they were well-prepared for evolving compliance requirements.

Simplified Compliance Management

Genetesis found the product remarkably user-friendly. It made overseeing their ISO 27001 certification, CAPA, HIPAA compliance efforts, supplier risk, and asset management a breeze. This simplicity empowered them to proactively handle risk and compliance tasks efficiently.

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