Quality and Regulatory

Medical Device and Life Science Manufacturing
Built on Quality and Compliance

World-Class Quality Systems for Regulated Medical and Life Science Products

FIH Health & Biotech is a global ISO 13485–certified medical device manufacturer and life science contract manufacturing organization (CDMO) committed to meeting the highest standards of quality and regulatory compliance across the entire development and manufacturing lifecycle. We support regulated medical devices, diagnostics, and life science instruments from early development through scaled manufacturing, ensuring that products are designed, manufactured, and documented in accordance with global regulatory requirements.

The quality and regulatory framework employed is supported by documented procedures, trained personnel, and continuous system oversight. Governance structures ensure consistent application of quality controls across all regulated activities while supporting continuous improvement and regulatory alignment over time.

Our quality management system supports innovation with uncompromising compliance, enabling smoother regulatory processes and accelerating commercialization.

As an ISO 13485–certified medical device manufacturer, FIH Health & Biotech provides medical device contract manufacturing and life science CDMO services supporting regulated product development, design transfer, process validation, and manufacturing operations. We perform medical device assembly, diagnostics manufacturing, and life science instrument production within controlled, audit-ready environments.

ISO 13485:2016–Certified Quality Management System

FIH Health & Biotech’s ISO 13485:2016 certified Quality Management System (QMS) is specifically designed for medical device and life science development and manufacturing environments.

Our QMS is aligned with:

FDA 21 CFR Part 820 (Quality System Regulation) and Part 11 (Electronic Records and Electronic Signatures)
Applicable EU IVDR and MDR requirements
Global medical device quality standards

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This structured framework governs all quality-critical activities across design, manufacturing, validation, assembly, and supply chain operations, ensuring consistency, traceability, and audit-readiness at every stage.

Quality-First Medical Device Development

Design for Compliance (DfC)

Regulatory success starts at device design and development. FIH applies a Design for Compliance (DfC) methodology that integrates regulatory requirements, risk management, and quality controls directly into the product development lifecycle.

This approach supports:

Design controls in accordance with 21 CFR 820.30 and ISO 13485 requirements
Risk-based decision-making (ISO 14971-aligned)
Manufacturability, scalability, and commercialization from day one
Reduced regulatory risk during verification, validation, and design transfer

By embedding compliance and regulatory frameworks early in the medical device development process, we help customers avoid late-stage redesigns to reduce development costs and accelerate time to market.

Medical Device Manufacturing & Assembly Validation

Medical Device Process Validation (IQ/OQ/PQ)

FIH executes comprehensive Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) procedures to validate manufacturing equipment, processes, and workflows.

These validations ensure:

Processes operate within defined and controlled parameters
Outputs consistently meet product specifications and regulatory requirements
Manufacturing systems enable compliant scalability
Regulatory documentation supports inspections and submissions

This disciplined validation framework supports low-volume assembly, scaled workflow automation, and high-volume medical device manufacturing.

Data-Driven Quality Control

Statistical Process Control (SPC) in Medical Device & Life Science Manufacturing

FIH Health & Biotech applies Statistical Process Control (SPC) across regulated medical device and life science manufacturing and assembly operations to ensure processes remain stable, capable, and compliant throughout the product lifecycle.

SPC is used to continuously monitor critical-to-quality (CTQ) characteristics and key process parameters, enabling early identification of variability before it impacts product performance or regulatory compliance. This proactive, data-driven approach supports ongoing process control meeting ISO 13485:2016, FDA 21 CFR Part 820 requirements.

Why SPC Matters in Regulated Environments

In regulated medical and life science manufacturing, uncontrolled process variation introduces risk to product safety, regulatory approvals, and long-term manufacturability.

FIH’s SPC framework enables customers to:

Detect process drift early, reducing nonconformance, scrap, and rework
Demonstrate sustained process capability and control, supporting validation, revalidation, and inspections
Improve yield, consistency, and reliability across complex, high-mix production
Support objective, data-backed decisions for continuous improvement, CAPA, and change management

By applying SPC at both development and production stages, FIH helps ensure that manufacturing processes scale without loss of control or regulatory confidence.

SPC data is captured and managed within FIH’s digital quality systems, enabling full traceability, deviation management, and audit-ready documentation across the manufacturing lifecycle.

Digital Traceability & Documentation

Electronic Batch Records, Deviation Management, and Audit Readiness

FIH Health & Biotech maintains a digital, end-to-end traceability and documentation framework designed to meet the rigorous data integrity and documentation requirements of regulated medical device and life science manufacturing.

Our quality systems utilize electronic batch records (EBR) and real-time deviation management to ensure that manufacturing data is accurate, complete, secure, and readily accessible for internal review, customer oversight, and regulatory inspection.

Built for Regulatory Confidence and Transparency

Digital traceability is essential for demonstrating compliance with ISO 13485, FDA 21 CFR Part 820, and global regulatory expectations.

FIH’s approach enables:

End-to-end product and process traceability across manufacturing and assembly operations
Real-time identification, documentation, and resolution of deviations
Clear linkage between process data, nonconformances, and corrective actions (CAPA)
Efficient, audit-ready documentation for FDA, ISO, EU IVDR and MDR, and customer audits

Manufacturing records, Device History Records (DHR), Device Master Records (DMR), deviations, and corrective actions are maintained in a controlled digital environment in accordance with 21 CFR Part 820 documentation requirements, supporting data integrity, version control, and long-term record retention.

Closed-Loop Quality Through Integrated Systems

FIH’s digital quality infrastructure is directly informed by SPC and process monitoring data, creating a closed-loop quality system that connects real-time manufacturing performance with documented compliance.

This integration ensures that:

Process trends trigger timely investigation and action
Deviations are evaluated using objective manufacturing data
CAPAs are data-driven and effective
Quality systems scale seamlessly with production volume and complexity

By uniting statistical process control with digital traceability and documentation, FIH delivers a transparent, defensible, and regulator-ready manufacturing environment trusted by leading medical and life science OEMs.

A Trusted Medical Device CDMO for Regulated Manufacturing

The FIH Advantage in Quality & Compliance

As part of Foxconn, FIH Health & Biotech combines global manufacturing infrastructure with mature, enterprise-grade quality systems trusted by leading OEMs worldwide.

Our teams bring deep experience supporting:

FDA inspections
EU IVDR and MDR conformity assessments
ISO certification audits
Complex, multi-site regulated programs

Compliance is embedded across design, manufacturing, documentation, and supply chain operations—reducing risk, improving predictability, and accelerating scale with confidence.