Services Tailored to the Medical Device and Health Software Industry
Our services are designed to meet the diverse needs of medical device and health software manufacturers, from quality management to regulatory compliance. Our approach combines technical expertise with a flexible, results-driven mindset to deliver the best outcomes for your business.
Service Descriptions:
Quality Foundations Suite
Establish a strong foundation for sustainable quality excellence:
Tailored Quality Management System (QMS) Design
Compliance Gap Analysis & Readiness Audits
ISO 13485 Implementation and Certification Support
Continuous Improvement Programs (Lean, Six Sigma, QbD)
Supplier Quality and Performance Management
Regulatory Navigator Services
Navigate the complex landscape of global regulations with confidence:
Regulatory Pathway Strategy for Global Markets (FDA, EU MDR/IVDR, TGA, etc.)
Pre-Market and Post-Market Submission Guidance
Clinical and Technical Documentation (CER, PER) Preparation
Harmonised Global Compliance Solutions
EU MDR/IVDR Transition Support
Risk Shield Solutions
Proactively manage risk to safeguard your product lifecycle:
Comprehensive Risk Management Frameworks (ISO 14971)
Risk Identification, Mitigation, and Monitoring
Hazard Analysis for New and Legacy Devices
Risk Documentation Alignment with Regulatory Standards
Digital Edge Consulting
Empowering software-driven innovation with digital compliance:
Software Quality Assurance (IEC 62304 and Beyond)
Cybersecurity Readiness and Compliance (FDA, NIST, EU MDR)
Validation of Software and AI-Driven Medical Devices
Lifecycle Accelerator Programs
Streamline product development while ensuring compliance:
Design History File (DHF) Development and Maintenance
Device Master Record (DMR) Setup
Process Validation and Qualification Plans
Human Factors and Usability Engineering Integration
Post-Market Surveillance and Vigilance Support
Insightful Learning Lab
Upskill your teams with knowledge that drives innovation and compliance:
Bespoke Quality and Regulatory Training Programs
FDA Inspection Readiness and Mock Audits
Internal Auditor Certification (ISO 13485, Risk Management, etc.)
Software Validation and Cybersecurity Workshops
Rapid Updates on Emerging Global Regulations
Precision Remediation Services
Turn challenges into opportunities with expert remediation support:
CAPA and Regulatory Non-Conformance Management
Warning Letter and Audit Response Strategies
Recall Support and Root Cause Investigations
End-to-End Quality System Remediation
Documentation Cleanup and Harmonisation
Future-Ready Compliance Frameworks
Build systems that adapt to today’s demands and tomorrow’s challenges:
e-QMS Implementation for Digital Transformation
Smart Document and Change Control Systems
Modular and Scalable Quality Architectures
Sustainability-Driven Quality Practices
Customisation Options
Clients can mix-and-match services based on their immediate needs, lifecycle stages, or long-term goals:
Essentials: Quick-start packages for startups or SMEs.
Advanced: Comprehensive programs for established organisations scaling globally.
Bespoke Solutions: Fully tailored packages aligned with client-specific requirements.