Expert Regulatory Consulting For MedTech
30+ years of hands-on experience guiding single-use, reusable, active, and SaMD devices through European and Malaysian approval processes.
The EAP Difference
You need more than documentation support. You need a regulatory partner who understands the nuances of both European MDR requirements and Asian market realities—someone who's been in the trenches for three decades, not a junior consultant learning on your project. mdr compliance medical device consulting medical devices
- Work directly with a principal consultant, not a rotating team of junior staff. Get 30+ years of regulatory knowledge applied specifically to your device.
- Unique combination of EU MDR mastery and Malaysian market presence. Whether you're an Asian manufacturer entering Europe or a European company seeking Malaysian registration, we bridge both worlds.
- Beyond documentation—we provide interim management, quality assurance, manufacturing, and identification of contract-manufacturing service providers. True operational partnership. mdr compliance medical device consulting
Core Services
EU MDR Compliance Consulting
Master the complexities of EU Regulation 2017/745. From gap analysis and technical documentation to Notified Body liaison and post-market surveillance.
- Technical Documentation (Annex II & III)
- Biocompatibility Evaluation Assessment
- Clinical Evaluation Reports (CERs)
- ISO 13485 QMS Development
- Notified Body Preparation
Malaysia Device Registration
Navigate MDA requirements with local expertise. We serve as your Local Authorized Representative (LAR) and guide your devices through the complete registration process.
- LAR Services (MDA 2012 Compliant)
- Class A/B/C/D Registration
- CSDT Preparation
- MDA Audit Preparation
ISO 13485 QMS Guidance
ISO 13485 QMS Guidance
Build a robust Quality Management System that satisfies global requirements. From gap analysis to certification preparation, we ensure compliance excellence.
- Gap Analysis & Remediation
- QMS Design & Implementation
- Procedure Documentation
- Internal Audit Training
Who We Serve
ASIAN Manufacturers
Breaking into European markets? We understand your business culture and can translate Asian manufacturing excellence into EU-compliant documentation and processes.
EUROPEAN Companies
Expanding to Southeast Asia? Leverage our Malaysian presence and MDA expertise to efficiently register your devices in high-growth Asian markets.
MedTech Start-Ups
MedTech Start-Ups
From concept to market. We provide regulatory strategy, manufacturing setup and quality assurance guidance for innovative medical device projects.
Device Expertise
Single-Use Devices
Active Medical Devices
Reusable Instruments
Syringes, catheters, drapes, diagnostic kits
Reusable Instruments
Active Medical Devices
Reusable Instruments
Surgical instruments, endoscopes, sterilizable tools
Active Medical Devices
Active Medical Devices
Active Medical Devices
Monitors, pumps, therapeutic equipment, wearable devices
Implantable Devices
Implantable Devices
Active Medical Devices
Orthopedic, cardiovascular, neural implants
Medical Software
Implantable Devices
Medical Software
SaMD, device software