Our Services

Specialized Consulting Across the Full Product Lifecycle

Project-based expertise in regulatory affairs, quality systems, intellectual property, engineering, and manufacturing — plus interim executive leadership when you need it.

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01 · Regulatory & Quality

Regulatory Affairs & Quality Systems

We help orthopedic and spine device companies build compliant, audit-ready quality systems and navigate FDA submissions with precision.

  • ISO 13485 and MDSAP QMS setup, auditing, and optimization

  • SOP and Quality Manual development

  • Non-conformance and CAPA resolution

  • FDA 483 response and remediation

  • Full FDA 510(k) preparation — predicate evaluation, testing strategy, and eSTAR submissions

  • Establishment registration and device listing

  • Project-based or interim remote VP of RA/QA leadership

A document titled 'Quality Management System Documentation and Audit Checklist' with sections on documentation hierarchy, key QMS documents, audit summary, and a legend explaining symbols. The top left features the 'Quality First Medical Devices' logo and the title 'Quality Management System.'
Technical drawing of a dental implant with views from different angles, labeled with parts including spiral rod, tulip head, threaded shank, head width, thread, internal thread, and rod seat.

02 · Intellectual Property

Intellectual Property Strategy

With 30+ issued patents among our consultants, we help you protect what makes your technology defensible — from first concept to portfolio strategy.

  • Concept development and patent landscape analysis

  • Provisional patent drafting and filing support

  • Professional patent drawings

  • Seamless handoff to patent counsel

  • Patent due diligence reports

  • IP portfolio strategy for orthopedic and spine technologies

See the IP Page

03 · Operations

Business Formation & Operational Excellence

We help founders move fast without cutting corners — standing up the operational backbone your company needs to scale.

  • Business entity formation and filings

  • Rapid professional website setup

  • ERP and eQMS implementation and training

  • Full RA/QA, Engineering, and Manufacturing department build-out

  • Business and operational gap analyses

  • Project management software setup and training

Three people in a business meeting looking at a large digital dashboard displaying project management and system status metrics. One woman is pointing at the screen, a man is seated working on a laptop, and another woman stands listening.
A man with glasses and a dark shirt is sitting at a desk, reviewing documents and writing with a pen. There is a computer monitor displaying a chart, and a whiteboard with a process flow and text in the background.

04 · Engineering

Engineering, Design Controls & Validation

Rigorous design control processes reduce risk and accelerate your path to clearance.

  • Design History File (DHF) development

  • Test method development and evaluation reports

  • Design V&V planning and execution

  • ISO 14971 risk management integration

  • Design control process implementation

05 · Manufacturing

Manufacturing & Supplier Quality

From supplier qualification to scale-up, we help you build a resilient, compliant supply chain.

  • Supplier qualification, selection, and auditing

  • Manufacturing process development and scale-up support

  • Supply chain risk assessment

Three medical professionals in a clean laboratory working on spinal implants. The room features signs with information about the production line, performance metrics, and certification standards. One person is reviewing documents, while the other two examine metal spinal implants on tables.

06 · Executive Support

Interim C-Level Leadership

Sometimes the fastest path forward is experienced leadership — for a project, a submission, or a transition period. Texas Bioventures provides project-based or interim executive support for:

VP of Regulatory Affairs

VP of Quality

Engineering Leadership

Operational Leadership

Discuss Interim Leadership

Texas Bioventures, a consulting agency that is a dba of Veritas Prism LLC, provides strategic consulting and support services. We do not guarantee regulatory outcomes, clearances, or commercial success. All engagements are project-based and tailored to each client's specific needs.