Expertise
LuQA helps MedTech companies navigate regulatory compliance and quality management through digitalization, automation, and AI-driven innovation.
Rethinking Consulting
From reactive compliance to proactive strategy
Traditional consulting models are outdated. While many firms rely on manual processes and rigid structures, LuQA takes a different path — combining deep regulatory expertise with intelligent, digital solutions.
At LuQA, I focus on automation, AI, and data-driven processes to make compliance faster, leaner, and more intelligent.
This isn’t about creating more documentation — it’s about creating real business value by aligning regulatory processes with strategic growth and innovation.
Global Market Access — Simplified
From MDR to FDA — global compliance, simplified
LuQA enables MedTech companies to access international markets confidently and efficiently.
Through my global partner network, I help clients design and execute market-specific regulatory strategies for major jurisdictions:
- EU MDR (2017/745) and CE marking
- FDA (21 CFR 820, QMSR) submissions and inspections
- MDSAP readiness and global QMS alignment
- Health Canada and ANVISA (Brazil) requirements
- Japan (PMDA, MHLW) regulatory pathways
Whether preparing for MDR compliance or managing MDSAP audits, I help teams transform regulatory challenges into market opportunities.
Digital & AI-Driven Regulatory / Quality Transformation
Digital tools meet regulatory intelligence — helping RA and QM evolve from cost centers to strategic enablers
LuQA helps MedTech organizations modernize their Regulatory Affairs (RA) and Quality Management (QM) functions to stay competitive in the new AI era. I support companies not only with digital tools and automation, but also with the strategic and cultural transformation needed to make RA and QM future-ready.
Focus areas:
- Modernization of QA/RA organizations by designing AI-driven processes
- Moving from document-based to data-based compliance for accelerating submissions and reducing time-to-market
- Selecting and integrating SaaS tools for QA/RA efficiency
- Building ISO 13485 and FDA QMSR compliant digital QM Systems
- Supporting in drawing up technical documentations and submission files covering relevant standards such as IEC 62304, IEC 62366-1 and ISO 14971
As Head of Growth at CertHub, I also drive innovation in digital compliance platforms — automating documentation, enabling data-driven regulatory intelligence, and freeing experts to focus on strategy rather than administration.
Smarter compliance.
Faster market access.
Digital innovation.
Services
From concept to certification — LuQA builds smarter, future-ready compliance systems
Regulatory &
Market Access Strategy
Digital Transformation
in QA & RA
SaaS / Tool Evaluation
& Implementation
Creating technical documentations
& supporting
with regulatory submission (EU/MDR, FDA, MDSAP)
Establishing digital Quality
Management Systems
Supporting with Audit/Inspection Preparation
& Gap Assessments
About
I’m Luca Salvatore, founder of LuQA and long-time consultant in Regulatory Affairs and Quality Management.
Before starting LuQA, I spent over a decade at the Johner Institute, where I built international RA consulting teams, led digital transformation initiatives, and developed strategies for AI/ML-based medical devices and de novo technologies.
With a computer science background and 15+ years in MedTech, I bridge regulatory depth with technological innovation — helping companies remain compliant, agile, and competitive.
Expertise highlights:
- International Regulatory Strategies & Market Approval
- Digital, data-driven technical documentations and QM Systems
- AI-enablement for QA/RA
- EU/MDR, FDA, MDSAP and further jurisdictions