Regulify.AI provides a closed-loop platform where eQMS, Risk, Clinical Evidence and Product documentations stay in sync, automatically.
Traditional regulatory platforms digitize compliance work. Regulify digitizes regulatory reasoning, the same intelligence whether you're a five-person startup or a global life sciences company.
Unlike today's reactive, fragmented compliance systems, we deliver proactive insights that accelerate innovation, reduce compliance costs, strengthen patient safety, and enable organizations to confidently meet global regulatory requirements throughout the entire product lifecycle.
Our platform manages compliance as a living, intelligent ecosystem. Built for medical device manufacturers, it unifies the entire product lifecycle, from Design Controls, eQMS, and Change Management to live Design Input–Output Verification & Validation (DIOVV) impact analysis, continuous Risk Intelligence, and Post-Market Surveillance.
Traditional eQMS platforms treat quality events, design changes and risk management as separate workflows. A single engineering change can require updates across design controls, risk analyses, verification testings and CAPAs, coordinated manually across teams and systems.
By connecting quality, engineering, regulatory, manufacturing, and field performance data into a single intelligence layer, the platform automatically identifies change impacts, predicts downstream risks, maintains end-to-end traceability, and ensures regulatory readiness in real time.
Our intelligent modules are designed to automate high-effort, compliance-driven activities within Medical Device Quality and Regulatory processes. The platform streamlines repetitive, time-consuming, and rules-based tasks while ensuring complete auditability, traceability, and adherence to global regulatory requirements. By standardizing workflows, reducing manual effort, and maintaining comprehensive electronic records, the solution improves operational efficiency, minimizes compliance risk, and enables quality and regulatory teams to focus on higher-value activities.
From thousands of publications to a defensible Clinical Evaluation Report (CER) in days.
Clinical Evaluation Reports often require reviewing hundreds to thousands of publications, extracting evidence manually and maintaining traceability. Literature review is one of the most labor-intensive regulatory tasks.
Smart evidence search, extraction and citation generation, with a human review step at every claim so your clinical experts are empowered but remain responsible.
Replace costly external document reviews with our smart compliance checker. Instantly identify gaps against medical device regulatory and quality guidelines, accelerate submissions, and deliver audit-ready documentation with greater confidence.
Companies must continuously comply with FDA-QMSR, EU-MDR, ISO 13485, IEC 62304, ISO 14971 and various other applicable regulations, standards & guidelines. Compliance is still largely maintained through manual audits (internal and external).
Automated review against the live regulatory corpus. Every gap surfaced with clause-level rationales, and suggestions to be in-complaint.
Discover. Analyze. Visualize. Predicate Finder transforms FDA 510(k) data into meaningful insights. Search and compare cleared devices, identify potential predicates, analyze manufacturer portfolios, explore product codes, monitor technology trends, and visualize clearance activity through intuitive dashboards. Whether you're planning a regulatory strategy, benchmarking competitors, evaluating market opportunities, or researching emerging technologies, Predicate Finder delivers the intelligence you need, all in one place.
Regulatory professionals spend countless hours manually searching FDA databases, comparing devices, and analyzing predicate suitability. Existing tools provide data but lack the intelligence, visualization, and insights needed to quickly identify market trends, benchmark competitors, and make informed regulatory decisions.
Predicate Finder transforms FDA clearance data into regulatory intelligence. Unlike traditional search tools, it identifies relevant devices, uncovers competitive landscapes, and visualizes market trends, providing actionable insights for faster, smarter decision making for regulatory and product strategy.
A risk intelligence engine that transforms device information into actionable ISO 14971 risk insights, enabling faster and more comprehensive risk management.
Creating a medical device risk management file is a time-intensive process requiring deep product knowledge and cross-functional collaborations. Teams spend weeks identifying hazards, foreseeable misuse, hazardous situations, and risk controls through manual reviews and brainstorming.
A knowledge layer that has learned from thousands of medical device risk scenarios, regulatory expectations, standards, and industry experience to suggest smarter, device-specific risk recommendations.
Know the regulatory impact of every change before it becomes a compliance risk. Change Clarifier uses a structured automated framework with regulatory intelligence to evaluate device changes against FDA and EU MDR expectations, helping teams determine whether a change requires a Letter to File, documentation update, or a new submission.
Medical device companies make hundreds of design, software, manufacturing, labeling, and supplier changes. Determining whether a change requires documentation only, a Letter to File, or a new regulatory submission requires significant regulatory expertise and manual review of guidance documents, previous assessments, and regulatory history to determine the impact of a change, often involving multiple Quality, Engineering, and Regulatory reviews.
Change Clarifier transforms regulatory change assessment from a manual interpretation process into an structured decision support framework, combining regulatory guidance, and device context to help teams make faster, more consistent decisions.
Creates a continuous cybersecurity intelligence layer that connects software components, vulnerabilities, threats, mitigations, and regulatory evidence, helping medical device teams stay compliant as products evolve.
Medical device cybersecurity documentation requires coordination between Software, Engineering, Quality, and Regulatory teams. Creating threat models, SBOMs, vulnerability assessments, and secure development evidence is complex, fragmented, and difficult to maintain as software and dependencies change.
CyberSteth brings cybersecurity risk analysis and regulatory documentation together in one platform. It generates threat models, SBOMs, and secure development evidence while maintaining a living cybersecurity record that evolves with your codebase and dependencies.
Decades of MedTech engineering, quality and audit experience, encoded into the product, so it works alongside your team from day one.
We understand that medical device development involves sensitive intellectual property. That's why we've built our platform with security, privacy, and data ownership as core principles.
All templates, files, and outputs are customer-owned and isolated per account. Regulify never shares, sells, or accesses your content without your explicit consent, ensuring your intellectual property remains secure.
We implement strict privacy controls with customizable anonymization and retention policies. Our AI systems ensure zero data retention with external LLM providers, maintaining complete confidentiality of your sensitive medical device information.
Regulify follows enterprise-grade security standards built on AWS infrastructure. While we pursue SOC 2 Type II and HIPAA compliance, our current security framework ensures robust protection through encrypted data transmission, secure cloud storage, and comprehensive access controls.
While we are actively pursuing SOC 2 Type II and HIPAA compliance certifications, we currently maintain enterprise-grade security standards that ensure your medical device data is protected with the highest levels of security, privacy, and confidentiality throughout your development journey.
30-minute walkthrough. Bring a real design change, quality event or literature question, we'll show the closed-loop working end-to-end.
