At Quality Commercial Consultants, we specialize in helping companies navigate complex regulatory landscapes, optimize quality management systems, and implement robust cybersecurity frameworks.

With decades of experience in FDA and EU medical device compliance, and cybersecurity compliance for regulated industries, we provide tailored solutions that ensure product success from concept to market.

Our expertise includes:

• Regulatory Strategy & Compliance – FDA, EU MDR, ISO 13485, and global regulatory approvals

• Quality Systems & Risk Management – ISO 14971 risk management, QMS optimization, and audits

• Cybersecurity Compliance – FDA, NIST, Homeland Security, AAMI TIR57, HIPAA/GDPR compliance, and AI/ML security

• Human Factors & Usability – IEC 62366-1 compliance and user-centered design validation

• Process Optimization & Market Access – Lean methodologies for global regulatory success

We partner with startups and established manufacturers to streamline compliance, reduce risk, and accelerate time to market—ensuring your innovations reach patients safely and efficiently.

Let’s work together to bring your medical device to market with confidence.