Ground-up design of ISO 13485-aligned quality management systems, structured to satisfy FDA QMSR and MDSAP requirements within a single system rather than parallel ones.
What this covers
Design and implementation of ISO 13485:2016-compliant quality management systems
Documentation hierarchy — quality manual, procedures, work instructions, forms
Process mapping and validation across design, production, and post-market activities
CAPA, nonconformance, and corrective action system design
Document and record control infrastructure
Alignment with FDA QMSR (21 CFR 820 transition) and MDSAP-ready system design
Internal audit program structure and management review frameworks
When this is typically needed
Establishing a QMS pre-market, before first regulatory submission
Transitioning from legacy FDA QSR to QMSR
Expanding into multiple regulated markets under MDSAP
Harmonizing an existing ISO 13485 system with FDA expectations