Bold Type: Accelerating Medical Device Apps With Proprietary Foundation App Starter Kit And Fast FDA Compliance

The Silicon Review

In the regulated world of medical devices, product success hinges not just on innovation, but on usability, security, and compliance. Yet for many medical device companies—especially early-stage startups and mid-sized OEMs—developing software that meets both product goals and regulatory demands is a complex challenge. That’s where BoldType comes in.

BoldType is a specialized medical software engineering and cybersecurity firm that partners with medtech innovators to design, build, and launch connected medical devices with confidence. Based in Orlando and serving clients across the U.S. and beyond, BoldType brings together deep technical expertise, a proprietary software foundation, and built-in regulatory processes to accelerate time-to-market and reduce risk.

Their clients range from fast-scaling startups with no internal engineering team to larger device manufacturers that need specialized consulting on FDA cybersecurity readiness or third-party validation. BoldType’s strength lies in bridging the gap between product vision and regulatory reality, helping teams launch apps, firmware, and connectivity solutions that are intuitive, secure, and fully auditable.

Agile Innovation Meets Regulatory Expertise

Founded in 2016 and ISO 13485–certified, BoldType was born from the recognition that medical device development requires more than coding—it demands understanding the intersection of software, safety, and regulation . Headed by Dr. Jose Bohorquez, an MIT‑trained PhD with experience in semiconductors and IoT, the company brings a rare combination of technical depth and systems thinking.

BoldType’s in-house “App Foundation” jumpstarts projects—covering secure Bluetooth connectivity, authentication, cloud sync, OTA updates, and documentation. This reusable platform allows the team to begin at "50% ready" from day one, enabling rapid iteration and customization across iOS, android, desktop, web, and embedded platforms. With decades of experience, the team can deliver compliant software faster and more cost-effectively than in-house teams or traditional consultancies. The company prides itself on being a full-stack partner—whether you're building a new wearable, upgrading firmware, or preparing for FDA cybersecurity audits, BoldType offers depth at every stage of the product lifecycle.

Comprehensive Software & Cybersecurity Solutions

BoldType provides a modular suite of services tailored specifically to the needs of medical device manufacturers. Whether you're building a wearable, developing remote monitoring software, or preparing for FDA Section 524B compliance, BoldType’s offering is comprehensive and efficient.

Medical Device App and Embedded Software Development

BoldType designs and builds mobile, desktop, web, and embedded applications for medical devices that require secure, real-time connectivity. These apps often involve Bluetooth (BLE), Wi-Fi, LTE, or custom protocol integrations and include features like patient authentication, cloud sync, over-the-air (OTA) firmware updates, and clinician dashboards. Leveraging their in-house App Foundation, a reusable software stack with prebuilt modules for secure communication and user interfaces, BoldType accelerates development by starting projects up to 50% complete—saving time without compromising customization or compliance.

Cybersecurity Consulting & Compliance

Under its dedicated CyberMed offering, BoldType provides full-spectrum cybersecurity services aligned with the FDA’s latest premarket guidance. This includes security risk analysis, threat modeling, software bill of materials (SBOM), penetration testing, encryption architecture, anomaly detection logic, and the creation of a Cybersecurity Management Plan and Software Security Requirements Specification (SSRS). The team ensures that cybersecurity is integrated from design through deployment—not bolted on at the end.

Regulatory Documentation & Support

From design history file inputs to usability studies and verification reports, BoldType packages software artifacts into FDA-ready submissions—saving clients time, cost, and compliance headaches.

Independent Verification & Validation

For clients with in-house engineering and firmware teams, BoldType acts as a trusted third-party reviewer—providing audits, security reviews, and documentation needed for FDA approval.

Launch with Confidence, Comply with Ease

In a world where medical device software must meet high standards for safety, security, and usability, BoldType offers a turnkey solution. Their specialized focus, proprietary tooling, technical depth, and regulatory know-how make them a reliable partner for organizations aiming to bring compliant, connected medical devices to market quickly. With BoldType, innovation isn’t held back by software risk—it’s propelled forward by precision engineering and trusted compliance.

Dr. Jose Bohorquez | Founder & President

Dr. Jose Bohorquez founded BoldType after earning his PhD in electrical engineering and computer science from MIT, pairing deep technical expertise with systems-level thinking . Over a career spanning semiconductor, IoT, and healthcare products, he has led teams in tackling embedded software, firmware, and cybersecurity for regulated industries. At BoldType, he channels that experience into delivering solutions that align innovation with regulatory rigor. Under his leadership, clients have launched products in women's health, cardiac care, remote patient monitoring, and more—with cybersecurity and compliance built in from day one.