In MedTech, quality isn't optional—it's a regulatory mandate and a trust enabler. At Qualentra Global, we help medical device companies establish and sustain robust Quality Management Systems (QMS) aligned with ISO 13485, FDA 21 CFR Part 820, and global standards. Our services ensure your devices meet safety, performance, and compliance benchmarks across the product lifecycle while enabling operational efficiency and faster market approvals.
- QMS Implementation (ISO 13485 / 21 CFR Part 820)
- Gap Assessment and Internal Audits
- Document Control and SOP Development
- CAPA, Risk, and Change Management Systems
- Supplier Quality Management
- Regulatory Inspection Readiness & Support
End-to-End Lifecycle – 6 Stages of Quality Management
Gap Assessment & Planning
Identify current compliance gaps and create a roadmap tailored to regulatory requirements.
QMS Design & Documentation
Develop a customized QMS framework, including policies, SOPs, and forms aligned with ISO/FDA standards.
Implementation & Team Training
Deploy systems across departments and train personnel for compliant operations and documentation.
Audit Preparation & Execution
Conduct internal audits and mock inspections to ensure readiness for regulatory and certification audits.
Continuous Quality Improvement
Establish CAPA systems and risk-based thinking to drive ongoing improvements and mitigate future issues.
Sustenance & QMS Upgrade
Monitor QMS health, perform regular reviews, and support upgrades based on evolving standards or company growth.
100%
Audit Readiness
35%
Reduction in Compliance Issues
50+
Faster QMS Setup
Frequently asked questions
ISO 13485 is the global standard for medical device quality systems. It ensures product safety, process consistency, and is often a prerequisite for regulatory approvals and market entry.
Yes. Our team assists with 21 CFR Part 820 compliance through system design, documentation, training, and audit preparation specific to FDA expectations.
Absolutely. We provide periodic audits, QMS upgrades, and compliance check-ins to keep your system aligned with evolving regulatory and business needs.