Core Services Overview
EU MDR Compliance Consulting
Master the complexities of EU Medical Device Regulation (MDR 2017/745) with expert guidance through every stage of compliance.
WHAT WE DO:
- Gap Analysis & Regulatory Strategy
- Comprehensive assessment of current compliance status against MDR requirements, with detailed roadmap to certification
- Technical Documentation (Annex II & III)
Master the complexities of EU Medical Device Regulation (MDR 2017/745) with expert guidance through every stage of compliance.
WHAT WE DO:
- Gap Analysis & Regulatory Strategy
- Comprehensive assessment of current compliance status against MDR requirements, with detailed roadmap to certification
- Technical Documentation (Annex II & III) Complete development of device descriptions, design & manufacturing information, risk management files, and essential requirements checklists
- Clinical Evaluation Reports (CERs) MEDDEV 2.7/1 Rev 4 and MDR-compliant clinical evaluations including literature reviews, clinical data analysis, and benefit-risk assessments
- Post-Market Surveillance Systems, PMS plan development, PMCF strategy, PSUR preparation, and vigilance systems
- ISO 13485 QMS for MDR Quality management systems aligned with both ISO 13485:2016 and MDR requirements
- Notified Body Liaison
- Application preparation, query responses, and ongoing communication management
- EUDAMED Registration, Actor registration, UDI-DI assignment, and technical documentation uploads
IDEAL FOR:
- Manufacturers transitioning from MDD to MDR
- First-time EU market entrants
- Companies facing Notified Body review challenges
- Medical device startups seeking CE marking
- Manufacturers expanding product portfolios in EU
TYPICAL ENGAGEMENT:
Timeline:
3-12 months (device class dependent)
Investment:
Project-based pricing
Deliverables:
Complete submission-ready technical documentation
MALAYSIA Medical Device Registration
Navigate the Malaysian Medical Device Authority (MDA) registration process with local expertise and established LAR services.
WHAT WE DO:
- Local Authorized Representative (LAR) Services
- Registered LAR acting as your Malaysian legal representative for device registration and post-market compliance (MDA Act 2012 compliant)
- Device Classi
Navigate the Malaysian Medical Device Authority (MDA) registration process with local expertise and established LAR services.
WHAT WE DO:
- Local Authorized Representative (LAR) Services
- Registered LAR acting as your Malaysian legal representative for device registration and post-market compliance (MDA Act 2012 compliant)
- Device Classification & Pathway Determination
- Accurate classification per Malaysian Medical Device Regulations 2012 and selection of appropriate registration route CSDT File Preparation
- Complete dossier development for Class A, B, C, and D devices including all required documentation and supporting evidence
- MDA Liaison & Communication
- Query responses, clarification requests, and audit coordination
- Post-Market Notification Management Change notifications, renewal applications, and vigilance reporting
- Label Review & Compliance
- Malaysian labeling requirements including Bahasa Malaysia translations
IDEAL FOR:
- International manufacturers entering Malaysian market
- Companies requiring compliant LAR services
- Medical device distributors seeking registration support
- Asian manufacturers expanding within ASEAN region
- Companies with multi-country Southeast Asian strategy
TYPICAL ENGAGEMENT:
Timeline:
3-8 months (class and complexity dependent)
Investment:
LAR services from RM[X],000/year + registration project fees (e.g. CAB/MDA)
Deliverables:
MDA registration certificate + ongoing LAR representation
ISO 13485 Quality Management Systems
ISO 13485 Quality Management Systems
Build and maintain a robust Quality Management System that satisfies global regulatory requirements and drives operational excellence.
WHAT WE DO:
- Gap Analysis & Readiness Assessment
- Comprehensive evaluation of current QMS against ISO 13485:2016 requirements, FDA QSR, and MDR Chapter I
- QMS Design & Implementation
- Custom QMS developmen
Build and maintain a robust Quality Management System that satisfies global regulatory requirements and drives operational excellence.
WHAT WE DO:
- Gap Analysis & Readiness Assessment
- Comprehensive evaluation of current QMS against ISO 13485:2016 requirements, FDA QSR, and MDR Chapter I
- QMS Design & Implementation
- Custom QMS development aligned with your organizational structure, device complexity, and target markets
- Documentation Development
- Quality manual, procedures, work instructions, forms, and templates ready for certification audit
- Process Mapping & Optimization
- Workflow analysis and improvement recommendations for design control, purchasing, production, and post-market processes
- Internal Audit Program
- Audit planning, internal auditor training, and audit execution support
- Management Review Facilitation
- Structure and facilitation of management review meetings with compliant documentation
- Certification Body Liaison
- Application preparation, audit coordination, and corrective action support
IDEAL FOR:
- Companies seeking first-time ISO 13485 certification
- Manufacturers preparing for MDR Notified Body audits
- Companies facing certification audit non-conformities
- Startups building QMS from the ground up
TYPICAL ENGAGEMENT:
Timeline:
4-12 months to certification readiness
Investment:
From Rm[X],000 (scope dependent)
Deliverables:
Complete QMS documentation + certification readiness
Specialized & Additional Services
Interim Regulatory Management
Regulatory Strategy & Planning
Regulatory Strategy & Planning
Short-term or project-based leadership for regulatory affairs or quality management functions.
Applications:
- Cover during staff transitions or maternity leave
- Crisis management and remediation projects
- Regulatory department establishment
- Major compliance projects requiring additional expertise
Engagement:
3-12 months, on-site or remote
Pricing:
Monthly retainer or day-rate
Regulatory Strategy & Planning
Regulatory Strategy & Planning
Regulatory Strategy & Planning
High-level regulatory strategy for product development, market expansion, or portfolio optimization.
Applications:
- Multi-market entry planning (EU, Asia, US, etc.)
- Product classification and pathway determination
- Regulatory due diligence for M&A or investment
Engagement:
Workshop-based or consulting retainer
Pricing:
Day-rate or project-based
Malaysia Manufacturing Support
Regulatory Strategy & Planning
Malaysia Manufacturing Support
Guidance on manufacturing setup, sourcing, and outsourcing in Southeast Asian markets.
Applications:
- Manufacturing facility establishment
- Contract manufacturer evaluation and qualification
- Supplier audits and quality agreements
- Technology transfer and process validation
Engagement:
Project-based or advisory retainer
Pricing:
Custom based on scope