“Bold Type is a leading provider of secure software for medical device startups and OEMs.”

Bold Type only specializes in the creation of medical device apps with years of experience in making the most complex and secure software solutions for regulated markets. Their leadership team has utilized the massive experience to reimagine how medical device apps can be developed, allowing them to provide secure, FDA-compliant, and user-friendly applications. Their approach focuses on functionality, beauty, and speed, offering development services that strive to be of the highest standards in the industry. Specializing in medical device apps, Bold Type ensures that each project meets the most stringent usability, regulatory, and cybersecurity requirements. The company streamlines the development process to deliver these apps faster than most competitors while maintaining competitive pricing. Bold Type's mission is to simplify the process for clients, delivering medical device apps that are both secure and functional while complying with all relevant regulations.

Bold Type Services

Software Development for Medical Devices

Bold Type specializes in the development of secure and compliant software for medical devices including mobile apps, web applications, desktop software, and even embedded systems. The company has deep regulatory expertise as well as technical know-how for the delivery of FDA-compliant and fully functional software solutions. Bold Type's approach ensures that the software does not only meet the requirements of the medical industry but also designed with usability and security in mind.

The proprietary tools in the company's development process make it accelerate the timeline for the software development. The starter kits of Bold Type for medical device software get 50% of the development process done on the first day. From there, the team works closely with the clients to develop the software and make it meet specific functional and regulatory requirements. This efficient development process results in faster time-to-market and cost-effective solutions for clients.

Key Capabilities

• Full app and embedded development for medical devices.

• Experience in wireless communication technologies including BLE/Bluetooth, WiFi, Cellular, and proprietary solutions.

• Strong process and documentation support for FDA submissions and ongoing regulatory compliance.

Medical Device Cybersecurity Consulting

Bold Type provides specialized cybersecurity consulting to ensure that every medical device software meets the highest standards of security and regulatory compliance. By understanding the technical as well as the regulatory requirements, Bold Type minimizes risks from security and compliance. Cybersecurity consulting services from Bold Type encompass all critical activities, including penetration testing, up to preparation of necessary FDA documentation.

Cybersecurity Services

• System Architecture for Security: Bold Type will design secure systems from ground up with clients, with their software architecture following medical device security best practices.

• FDA Documentation and Compliance: Bold Type helps prepare all necessary cybersecurity documentation that needs to be submitted to FDA. This helps ease regulatory burden on the clients and ensures reduction of risks associated with non-compliance.

• Independent Testing: Bold Type offers independent testing services to ensure that the medical device software is secure and compliant with the required security standards.

Medical Device Software Consulting

Bold Type also offers expert software consulting services tailored to the unique challenges faced by medical device startups and OEMs. Regardless of whether a client is developing software in-house or engaging an external development team, Bold Type consultants provide strategic advice on everything from regulatory strategy to cybersecurity requirements. These consulting services are tailored to help companies navigate all the development stages-from early-stage startups transitioning from prototypes to formal product development and established companies looking for independent reviews of software and documentation.

Software Consulting Services

• Regulatory Strategy and Support: Bold Type assists customers in understanding the intricacies of medical device regulations, including how to comply with FDA standards and international standards.

• SOPs for Software Development Teams: The company offers SOPs that are tailored to software development teams, ensuring they are compliant with key standards such as ISO13485 (QMS), IEC62304 (Medical Software), ISO14971 (Risk Management), and ISO62366 (Human Factors).

• Independent Software and Documentation Review: Independent reviews of the software and the associated documentation at Bold Type ensure that all is done to the necessary medical device standards before submittal to regulatory bodies.

• Prototype to Product Development Transition: Bold Type supports the startup with a transition of the software from prototype to formal product development, which includes defining best practices and frameworks for FDA approval and market success.

Jose Bohorquez, PhD – President

Jose Bohorquez is the Founder and President of Bold Type, a company that helps organizations solve complex technical challenges. With more than a decade of experience in multiple industries, including semiconductor technology, medical devices, consumer electronics, health and fitness, and IoT, Jose brings his deep knowledge and expertise to Bold Type.

Mr. Jose earned a PhD in Electrical Engineering and Computer Science from the renowned Massachusetts Institute of Technology, also attaining a minor in business administration at Sloan School of Management. Therefore, his academic and industrious background puts Jose as the current front runner in technology innovation. Bold Type works on helping companies find better, state-of-the-art solutions when trying to develop medical device software in ways that are regulatory-compliant.

“What sets us apart is our innovative medical device app platform, designed to rapidly develop iOS and Android apps that seamlessly connect wirelessly to medical devices and the cloud.”