Navigate complex industry standards with confidence. MetalCore provides end-to-end regulatory support, quality management systems, and audit-ready documentation for globally compliant manufacturing.
In highly regulated industries, compliance isn't just a requirement—it's the foundation of patient safety, flight integrity, and operational excellence. MetalCore Manufacturing integrates regulatory compliance directly into our production lifecycle.
Our dedicated Quality & Regulatory Affairs team works alongside engineering, production, and procurement to ensure every component meets or exceeds the standards mandated by regulatory bodies worldwide.
FDA 21 CFR Part 820, ISO 13485
AS9100 Rev D, NADCAP
IATF 16949, VDA 6.3
ISO 9001, MIL-STD, API
Our management systems are independently audited and certified to the highest international standards across multiple industry verticals.
Quality Management Systems for consistent, repeatable manufacturing processes.
Aerospace-specific QMS with enhanced requirements for safety and risk management.
Medical device QMS focusing on regulatory compliance and product safety.
Automotive quality management emphasizing defect prevention and continuous improvement.
Quality System Regulation for medical device manufacturers in the United States.
Compliance with US export controls for defense and aerospace technologies.
From initial design controls to final shipment documentation, we provide comprehensive support to meet your regulatory obligations.
Design, document, and maintain quality management systems aligned with ISO, AS, and FDA requirements. Includes procedure development, training, and internal audit scheduling.
Complete Design History Files (DHF), Device Master Records (DMR), and process validation packages prepared for regulatory submission and audit readiness.
Structured change control processes, risk assessments (FMEA), and Corrective and Preventive Action systems to ensure compliance during product evolution.
Pre-audit gap assessments, mock audits, corrective action tracking, and dedicated audit coordination for FDA, Notified Bodies, and customer surveillance audits.
End-to-end batch/lot tracking, certificate of analysis (CoA) verification, and UDI/GTIN labeling support for regulated supply chains.
Role-based training programs for internal teams on regulatory requirements, documentation standards, and quality culture reinforcement.
Map applicable regulations, standards, and customer-specific requirements.
Evaluate current processes against compliance benchmarks.
Implement procedures, controls, and documentation frameworks.
Internal reviews, mock audits, and corrective action closure.
Ongoing compliance tracking, metric reporting, and system optimization.
Access our library of compliance checklists, regulatory templates, and industry guides to streamline your quality initiatives.
Comprehensive step-by-step guide for FDA 21 CFR Part 820 and ISO 13485 alignment.
Download PDF ↓Standardized documentation package for AS9100 customer and third-party audits.
Download PDF ↓Structured template for managing engineering changes with regulatory traceability.
Download PDF ↓Best practices for lot control, CoA verification, and supply chain compliance.
Download PDF ↓Whether you're preparing for an audit, implementing a new QMS, or seeking a certified manufacturing partner, our regulatory specialists are ready to assist. Schedule a confidential consultation today.