Pushing the boundaries of biomedical technology does not need increase the risk of running afoul of regulations. TextualMind’s technology helps identify regulatory risks proactively, so companies in industries such as medical devices, pharmaceuticals, and in-vitro diagnostics take action before they face costly regulatory compliance challenges.
REQUEST A DEMOFrom orthopedic screws to implantable pacemakers and neuroestimulators – medical devices must ensure patient safety while providing an effective therapy. To that effect, companies that sell medical devices in the US must comply with regulations including 21 CFR Part 820, issued by the FDA. In the European market, ISO 13485 plays an analogous role, and influences the regulations in countries such as Brazil and Japan.
The pharmaceutical industry is becoming increasingly complex – including the use of biotechnology to develop and manufacture new types of therapeutic agents, incorporating medication adherence technologies, and combining traditional pharmaceuticals, medical devices, and biological substances in a single product. Correspondingly, regulatory bodies have issued or updated their rules and guidance. In the US, this includes 21 CFR Part 210, 21 CFR Part 4, and 21 CFR Part 610, while ISO has issued ISO 15378 for pharmaceuticals distributed in the European market.
Strategic R&D, supplier, clinical studies, and manufacturing agreements abound in the life sciences industry: seldom does a single company have all the resources required to take a product from idea to commercialization. Furthermore, companies frequently decide to optimize their product portfolio and operations through mergers and acquisitions. The success of such partnerships and transactions hinge not only on financial performance and technology, but on the strength and consistent execution of their quality systems.
Upload company policies, procedures, work instructions, standard operating procedures, and quality records to our secure, encrypted cloud-based platform.
Documents are automatically categorized and reviewed against the applicable regulations, internal policies and procedures, regulatory body guidance, and industry best practices.
TextualMind’s artificial intelligence platform generates a risk rating for each document and regulatory area, and provides regulatory and process experts within the company with downloadable report of prioritized findings and actionable recommendations.
TextualMind’s artificial intelligence platform analyzes applicable regulations, company policies and procedures, as well as its quality records, in order to provide actionable intelligence that helps companies prioritize their efforts. Think of it as having a tireless, extremely knowledgeable, and always available internal auditor that is always up to date and is continuously reviewing your company's policies, procedures, and quality records in real-time.
TextualMind leverages the leading cloud computing provider, Amazon AWS, latests and most robust technology, and industry best practices to keep your data protected from unauthorized access.
Has over a decade's experience leading software teams within FDA-regulated industries, where he also developed AI systems. Holds a Computer Engineering degree with high honors from the University of Puerto Rico at Mayagüez, graduate coursework and professional education at UIUC and MIT.
gunther@textualmind.com 
Has over a decade's work of experience in the medical device industry. Holds an Industrial Engineering degree with high honors from the University of Puerto Rico at Mayagüez.
daisy@textualmind.com
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