§ 02.1 Quality
Quality Management
ISO-aligned quality management systems, audits, and design controls — built from gap analysis to ongoing internal review.
Robust quality management is the foundation of every regulated product. We design, implement, and remediate QMS frameworks aligned to ISO 13485, ISO 9001, and FDA 21 CFR 820 — from initial gap analysis through ongoing internal audits and management reviews. Whether you’re standing up a system from scratch or preparing for a notified body assessment, we focus on systems that scale with your organization rather than slowing it down.
§ 02.1.A What we deliver
Specific engagements in Quality.
- 01 Gap Analysis
- 02 Quality Management Systems Build and Implementation
- 03 Internal Audits / Supplier Audits / Mock Audits
- 04 Design Controls / Design History File
- 05 Design Verification and Validation
- 06 Reliability / Human Factors
- 07 Software Lifecycle Development
- 08 Risk Management
- 09 Complaint Handling
- 10 CAPA processes
- 11 Management Reviews