Qualio
Qualio is a unified quality and compliance platform that helps growing life sciences companies scale faster while staying continuously audit- and inspection-ready. Medical device, digital health, biotech, and pharma teams use Qualio to replace manual processes and disconnected tools with a single source of truth for quality, regulatory readiness, and risk.
With a modern eQMS at the foundation and Compliance Intelligence layered on top, Qualio moves teams beyond point-in-time audits. Automated gap analysis, cross-standard evidence mapping, and real-time readiness dashboards provide confidence that the organization is prepared today—not just when auditors arrive.
Qualio centralizes document control, training, CAPA, change management, supplier quality, and design controls, linking them directly to regulatory requirements and product lifecycle data. Executive-ready views show compliance health by standard, region, and product, turning regulatory readiness into a measurable business capability instead of a black box.
Compliance Intelligence continuously monitors for risk, highlights gaps early, and prioritizes remediation so teams focus effort where it matters most. Pre-validated regulatory frameworks are maintained as requirements evolve, reducing reliance on consultants and avoiding duplicate work as companies expand.
The result is faster market entry, lower compliance cost, reduced risk of findings or recalls, and confident, risk-managed growth.
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RegDesk
RegDesk stands out as the leading RIMS platform enhanced by AI, tailored specifically for Medical Device, Pharmaceutical, and IVD companies.
• Our unique Regulatory Intelligence encompasses data from over 120 countries, all presented in a uniform format, and includes timely alerts regarding regulatory updates.
• With our AI-driven Application Builder, regulatory affairs teams can efficiently create and submit global applications in a fraction of the usual time.
• The Change Assessment feature enables RA teams to evaluate the implications of changes on current products and determine the necessary actions.
• Our Distributor Collaboration tool facilitates smooth workflows for communication and document sharing with external partners.
• The Standards Management function simplifies the process for RA teams to locate and oversee both international and country-specific standards.
• Additionally, our Tracking & Reporting capability empowers teams to monitor regulatory initiatives worldwide, receive notifications for renewals, and quickly compile reports on key performance indicators.
To learn more about our offerings, please explore our website.
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meddevo
Meddevo provides a dedicated workspace for each team member, allowing them to create, manage, and automate the technical documentation related to medical devices and in vitro diagnostics (IVDs), functioning as a comprehensive SaaS solution. You can efficiently handle changes, Corrective and Preventive Actions (CAPAs), complaints, and tailored processes directly within the platform. Thanks to the seamless synchronization of the electronic Quality Management System (eQMS) and electronic Technical Documentation (eTD), you will achieve unparalleled visibility into your operations. This solution is designed to significantly decrease administrative workloads and streamline processing times, ultimately enhancing overall productivity. By leveraging these tools, teams can focus more on innovation rather than paperwork.
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C2P
Compliance & Risks collaborates with leading global brands such as Dyson, Bose, EPSON and Samsung to streamline the ESG and Product Compliance process, facilitating smoother market entry.
Our offerings include three essential components:
1. An enterprise technology solution designed to enhance productivity and efficiency through our C2P platform, featuring the most extensive regulatory content available, encompassing over 40 topics across more than 20 industries and covering 195 nations globally.
2. Access to a dedicated team of experts ready to provide answers to any regulatory inquiries you might encounter.
3. Assistance in monitoring and evaluating the relevant regulations and standards pertinent to your products and business, ensuring you can demonstrate compliance to sustain and grow your market presence.
With over two decades of experience, we have established a stellar reputation for effectively aiding iconic brands in managing compliance risks, allowing them to thrive in competitive markets. Our commitment to supporting our clients positions us as a trusted partner in navigating the complexities of regulatory environments.
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