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Call
Tel: +82 70-4799-7450
Fax: +82 2-6499-2406
MDR 2017/745
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Medical Device CE-Mark
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Documentation Audit
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On-Site Audit
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Product Realization
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Essential Requirements
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Risk Management
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Conformity Assessment
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Clinical Evaluation
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Usability and IFU
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Tests and Validations
Cybersecurity
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Medical Device cybersecurity
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EU MDCG 2019-16
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US FDA Guidance
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IEC TR 60601-4-5
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IEC 81001-5-1
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Security Requirements
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Threat Mitigation
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Vulnerability Testing
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Penetration Testing
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Technical Support
IVDR 2017/746
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Medical Device CE-Mark
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Documentation Audit
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On-Site Audit
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Product Realization
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Essential Requirements
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Risk Management
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Conformity Assessment
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Clinical Evaluation
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Usability and IFU
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Tests and Validations
ISO 13485
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Medical Devices Quality Management System
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Documentation Audit
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On-Site Audit
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System requirements
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Management Resonsibility
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Resource management
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Product Realization
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Measurements, analysis, and Improvement
ISO 9001
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QMS Certification
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Documentation Audit
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On-Site Audit
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Organization Context
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Leadership
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Planning
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Support
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Operation
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Performance Evaluation
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Improvement
ISO 22716
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GMP Requirements
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Personnel, Promises and Equipment
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Raw material and Finished products
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Wastes, Deviations and Subcontracting
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Feedback and Changes
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Internal audit
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Documentation
ISO 14001
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Environmental Management System Certification
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Documentation Audit
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On-Site Audit
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Document Requirements
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Management System Integration
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Design and Development
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Process Evaluation
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Performance Evaluation
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Improvement
FOOD SAFETY
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Ensuring Quality, Safety and Trust in the Food Industry
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ISO 22000
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HACCP
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Food Packaging
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Processed Foods
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Dairy Products
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Additives, etc.
MD/2006/42/EC
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Machinery Directive
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A/B/C Standards
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General Safety
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Specified Safety
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Safety Relevant Device and Parts
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Specified Machinery Requirements
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Safety aspects of Electricity, Distance and Temperature
CPR305/2011/EU
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Construction Product Regulation
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Building or Construction
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Essential Requirements
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Technical Specification
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Assessment of Performance and Verification of Constancy
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Laboratory Approvals
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Kind of Cement
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Thermal insulation
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Kind of Pipe
Lifts Directive
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Lifts and Safety Components for Lifts
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Essential Requirements
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Examinations and Tests
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Product Quality Assurance for Safety Components for Lifts
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Unit Verification
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Lift Testing
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Limits on Speed, Load and Power
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Energy Accumulating and Dissipating buffers
Training
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ISO13485:2016
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ISO22716
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CE Marking
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Auditor Training
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Lead Auditor
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Global Trands in Medical Devices
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Technical Documentation
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Talent Development