Security and Connectivity for the IoT Edge - Allegro Software is a leading provider of IoT Edge device security and connectivity software toolkits to manufacturers worldwide. Field-proven in 275+ million devices, our solutions enable Medical Device manufacturers and OEMs in Energy, Military, Enterprise, and Consumer markets to create connected secure devices using TLS, SSH, XML, JSON, FIPS validated cryptography and more.
BeanStock Ventures is 1 of 9 FDA-accredited Third Party Review Organizations globally which provides software development and regulatory compliance products and services to minimize complexity, and reduce cost and time to market of innovative medical devices.
BeanStock Ventures has over 140 years of combined experience in software development for the healthcare and life science space.
Digital.ai Application Security (formerly Arxan) protects smartphone apps that connect to medical devices. As an early innovator in this space, Digital.ai is used by some of the largest medical device makers, banks, and game companies worldwide to prevent applications from being run in unsafe environments, obfuscate code to prevent reverse engineering and safeguard user information and intellectual property. Digital.ai Application Security is ISO 13485 and ISO 27001 certified to serve the needs of medical device manufacturers.
Parasoft helps medical device development organizations continuously deliver quality software with its market-proven, integrated solutions for automated software testing. Supporting the embedded, enterprise, and IoMT markets, Parasoft’s technologies reduce the time, effort, and cost of delivering safe, secure, reliable, and IEC 62304 compliant software to meet FDA regulations by integrating everything from deep code analysis and unit testing to web UI and API testing, plus service virtualization and complete code coverage, into the delivery pipeline. Bringing all this together, Parasoft’s award-winning reporting and analytics dashboard delivers a centralized view of quality enabling organizations to deliver with confidence and succeed in today’s most strategic ecosystems and development initiatives—security, safety-critical, Agile, DevOps, and continuous testing.
Founded in 2019, Skyflow is a data privacy vault designed to isolate, protect, and govern sensitive data. The only comprehensive data privacy solution available today, Skyflow radically transforms how businesses handle their sensitive data, including their customers’ PII, healthcare and payment data. Skyflow has a global customer base that spans verticals like fintech, retail, travel and healthcare, and includes industry leaders like IBM. Skyflow is based in Palo Alto, California, with offices in Bangalore, India
Founded upon the premise that mobile security requires an entirely novel approach, Zimperium secures both mobile devices and applications so they can safely and securely access data. A single unified platform protects the endpoint and secures the entire application development cycle with the only on-device, machine learning-based engine. Zimperium provides visibility and protection against known and zero-day threats and attacks across device, network, phishing, and application threat vectors against Android, iOS, and ChromeOS devices. Headquartered in Dallas, Texas, Zimperium is backed by Warburg Pincus, SoftBank, Samsung, Sierra Ventures, and Telstra Ventures.
BioT provides a validated platform for building cloud-native medical devices together with user-facing applications - in a day instead of years. We power the clouds of dozens of medical device companies, from big enterprises to startups, in a variety of clinical domains.
It usually takes years to build systems that serve wide range of users, from clinicians and patients, to internal users (e.g. data scientists, operations, and technical support), all while complying with cybersecurity, HIPAA, and GDPR. With BioT it takes just one day!
Tricentis is a global leader in enterprise continuous testing. The Tricentis AI-powered, continuous testing platform provides a new and fundamentally different way to perform software testing. An approach that’s totally automated, fully codeless, and intelligently driven by AI. It addresses both agile development and complex enterprise apps, enabling enterprises to accelerate their digital transformation by dramatically increasing software release speed, reducing costs, and improving software quality.
Bene Studio is an end-to-end medical device software design and development consultancy. With the majority of our experts located in our EU offices, we can dedicate well-educated engineers to your projects at competitive prices for the long term. Our group serves as your MedTech talent pool for both team extension and managed projects, ranging from one dedicated expert to a team of 50. We cover UX, UI, and brand design, systems, and architecture design, cybersecurity, data, AI, cloud, IoT, mobile, web, and backend engineering, all with a focus on FDA, MDR, and ISO compliance.
At Enzyme, we believe your eQMS should make your job easier, not harder. Unfortunately, many eQMS implementations end up creating more problems than they solve. That’s why we designed Enzyme eQMS differently. Built by industry-veterans who understand the challenges of compliance firsthand, our eQMS is flexible, scalable, and easy to use, supporting the full product lifecycle. Serving teams from 2 to 2000, premarket to postmarket, Enzyme is the only eQMS you’ll ever need.
The RND Group is a Software Development company based in Indianapolis, Indiana that specializes in creating custom FDA-Regulated software with over 25 years of industry experience. The RND Group employs over 60 onshore Software Engineers with an average tenure of 15 years. We have developed over 100 FDA approved medical devices ranging from Class I-III, SaMD and RUO devices.
Our services include software requirements definition, design and development, verification, and validation for medical device software, as well as software regulatory consulting to help our clients with FDA regulations and cybersecurity. We are compliant with IEC 62304, ISO 13485, HIPPAA, IEC 62366, and CFR Part 820.
The RND Group has developed software for portable, POC, benchtop and large-scale analyzers. The RND Group’s software team can development software on any platform running any operating system (RTOS, Linux, Windows, Cloud), in a variety of languages. Our solutions are architected for maintainability and regulatory compliance.
We have worked with clients in the medical device industry, including startups, mid-size companies, and Fortune 500 companies to develop software for a range of medical devices, such as IVD, molecular, imaging devices, patient monitoring systems, and many more.
The RND Group is part of Gener8 who offers complete engineering services from product development through manufacturing and focus on commercializing complex instruments and consumables. With this Full Spectrum of Engineering Excellence, The RND Group / Gener8 can be your one stop shop for any Engineering project.