Medical Device and Pharma

Agile Central Inc > Medical Device and Pharma

Accelerating Innovation While Ensuring Patient Safety

The medical device and pharmaceutical industries face unique challenges balancing rapid innovation with stringent regulatory requirements. Our Life Sciences practice helps organizations accelerate time-to-market while maintaining compliance and ensuring patient safety.

Medical Device Solutions

Design Control Excellence Implement comprehensive design control processes that ensure compliance while accelerating development through automation and intelligent workflows.

Risk Management Integration Embed risk management throughout the product lifecycle with integrated FMEA, fault tree analysis, and risk mitigation tracking.

Verification & Validation Manage complex V&V processes with requirements traceability, test protocol management, and automated reporting for regulatory submissions.

Pharmaceutical Transformation

Drug Development Integration Connect discovery, development, and manufacturing data for seamless scale-up and technology transfer.

Batch Record Management Digital batch records with electronic signatures, deviation management, and automated review workflows.

Serialization Support Track and trace capabilities supporting global serialization requirements and supply chain security.

Digital Health Innovation

Software as Medical Device Manage SaMD development with integrated ALM, cybersecurity tracking, and continuous deployment capabilities.

Connected Device Management IoT integration for real-world evidence collection, remote monitoring, and predictive maintenance.

AI/ML Integration Manage AI/ML algorithm development with version control, training data management, and performance tracking.

Specialized Capabilities

DHF/DMR/DHR automation
Post-market surveillance
Combination product support
SOUP management
Clinical system integration

Regulatory Excellence

FDA Compliance

21 CFR Part 11 validation
Part 820 quality systems
Design control integration
510(k)/PMA support
Electronic signatures

Global Regulations

EU MDR compliance
ISO 13485 alignment
MDSAP support
Country-specific requirements
Regulatory intelligence

Quality Integration

CAPA management
Non-conformance tracking
Complaint handling
Audit trail maintenance
Document control

Clinical Integration

Trial data management
Protocol tracking
Adverse event integration
Statistical analysis
Regulatory submission