We specialize in application of quality 4.0 and integration of AI to enhance your QMS to meet or exceed FDA, EU and Global Regulations.
Mobile QARA Apps
User Experience
Device Design controls
Risk management
We are dedicated to providing utility in the enabling of a practical approach to Quality 4.0, meaningfully integrating advanced analytics, automation, and AI-based technologies to further enable Quality Management Systems for drugs, devices, and combination products. Our approach is novel to traditional quality management systems without deviating from the true fundamentals of regulation; i.e., design controls, risk management, data integrity, and lifecycle management.
Meaningfully integrating AI technologies in quality-related processes such as deviations, CAPA, change control, and PMS allows us to enable a future state of predictability for regulatory and compliance processes by allowing a meaningful approach to improving decision-making.
Our solutions are uniquely designed around the requirements of surpassing and/or satisfying FDA, EU MDR/IVDR, and other international regulatory requirements without compromising on a level of complexity. As a company with many decades of experience in the fields of device, diagnostics, and combo drug-device products, we are committed to the enabling of a truly future state quality system that is both designed to be compliant and aligned with the needs of the business and inspection process.
Our Design & Development Process
(in a nutshell)
Strategy & Roadmap.
Precision Regulatory Consulting develops a scalable, risk-informed roadmap aligned with the maturity of any sponsor. It helps early innovators lay compliant foundations and supports established organizations in optimizing, integrating, and future-proofing regulatory and quality systems across global product portfolios.
Visual & UX Design
We create highly intuitive training and instructions for use (IFUs) that are ready for review, allowing users to effectively use our products, speed through training, and get to market quickly. We combine the skill and expertise of human factors, user experience, and train-the-trainer to ensure success both before, during, and after product inspection.
Development
We build right-sized, inspection-ready Quality Management Systems from the ground up—or streamline existing frameworks—to support combination products and diagnostics without overburdening lean teams, ensuring compliance, clarity, and scalability even when resources are limited to a single contributor.
Inspection & Audit Readiness
We assist in maintaining inspection-readiness while boosting confidence through our use of structured dashboards and storyboards, which provide easy illustrations of control, compliance, and decision-making processes. Our quality data is therefore presented in an understandable, presentable, and compliant narrative format in line with FDA, Notified Body, and worldwide authority expectations.
What We Build For
CAPA
Complaints
Risk Management
Post Market Surveillance
Change Management
Design Controls
Purchasing Controls
Document Control
Purchasing Controls
Education & Learning
Case Studies
Case Study 1
Enabling Innovation and Quality
This in an actual case study of a company that integrated and used all resources horizontally to produce an innovated combination product without little dependency from suppliers or vendors
500+ Documents submitted • 100+ Document Reviews
Compliance Analytics Tracker
We can develop and help you monitor leading and lagging indicators for the health of your Quality Management System that result in quick fixes that prevent you from going into complex or uncessary CAPAs.
50k+ Downloads • 2k+ Reviews
4.4
What We Offer
Precision Regulatory Consulting delivers end-to-end regulatory and quality leadership across the product lifecycle, organized into three focused pillars:.
Product Development & Lifecycle Support
Integrated regulatory-quality execution supporting development, clinical operations, audits, and post-market activities—ensuring compliant, scalable, and commercially successful products.
Quality Systems & Compliance Excellence
Design, build, and remediation of inspection-ready QMS aligned with FDA QMSR, ISO 13485, ISO 14971, and EU MDR/IVDR—enhanced through pragmatic Quality 4.0 principles.
Regulatory Strategy & Submissions
Clear, risk-based pathways for FDA, EU, and global markets—covering combination products, medical devices, IVDs, and digital health, from IDE/IND through CE Mark, 510(k), PMA, and IVDR
User Centric Experiences
We design regulatory and quality solutions that fit the way a product is constructed, deployed, and remains in use. By integrating usability, human factors, and clinic workflow into the process, we can enable regulatory compliance that helps your product achieve safe user adoption, practical user experience, and strong user performance.
World-Class Regulatory & Quality Consulting
We work as strategic allies and help these teams transform regulatory requirements into tangible steps. Our objective is to deliver alignment across regulatory strategies, quality systems, and development goals.
Data analytics and reporting
We apply Quality 4.0 and AI principles to modernize QMS operations through data analytics, automation, and intelligent workflows. By improving visibility, trend detection, and governance, we help organizations move from reactive compliance to proactive quality oversight
Clinical & Investigational Readiness
We align quality and regulatory expectations early in development to support investigational studies and clinical execution. Our work emphasizes inspection readiness, data integrity, and traceability—helping teams progress through development with confidence and continuity.
Audit Readiness & Sustainable Compliance
We work with organizations to prepare for inspections and, in parallel, to create robust systems. Our focus is on sustained compliance-tuning processes, documentation, and governance so teams remain inspection-ready as products, pipelines, and regulations evolve over time.
Product & Regulatory Intergration
We support products that span drugs, devices, diagnostics, and software by aligning cross-regulatory requirements into a single operating model. This integration reduces complexity, clarifies accountability, and enables consistent compliance across the full product lifecycle.
Launched Devices and combination products
Average App Rating
documente reviewed
“Leonel brings a good experience at the intersection of Med device and combination product He is great guy to work with on combination products.”
Ram Halthore, Medical Device/Biotechnology Professional
“ Mr.Vanegas brings a remarkable blend of professionalism, analytical acumen, and innovative thinking to every project he undertakes. His deep understanding of complex data sets and health economics principles allows him to provide invaluable insights that drive effective decision-making and strategy development“
Anna Ogol, Healthcare & General Markets
“I had the pleasure of obtaining Leonel’s support at Precision Regulatory Consulting to build a blueprint based on regulatory requirements for selected jurisdictions. The level of professionalism was extraordinary. from great communication of project updates to timely project completion. I would highly recommend Precision Regulatory consulting.“
Laura Leal, Sr.Director QA/RA Life Sciences |Medical Device QA &RA
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