ISO 13485 — Medical Devices in Ukraine: 66427 specialists

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ISO Certification
- ISO 9001 — Quality Management
  Quality Management System Certification (ISO 9001)
  from 10,000 UAH
  ISO 9001 Certification Readiness Gap Analysis
  from 10,000 UAH
  Quality Management System Documentation Development
  from 10,000 UAH
  ISO 9001 Internal Auditor Training
  from 10,000 UAH
  Quality Management System Internal Audit
  from 10,000 UAH
  ISO 9001 Certification Audit Preparation
  from 10,000 UAH
  ISO 9001 Recertification Support
  from 10,000 UAH
- ISO 14001 — Environmental Management
  Environmental Management System Certification (ISO 14001)
  from 10,000 UAH
  Environmental Aspects and Risk Analysis
  from 10,000 UAH
  ISO 14001 Environmental Documentation Development
  from 10,000 UAH
  ISO 14001 Environmental Requirements Staff Training
  from 10,000 UAH
  Internal Environmental Audit
  from 10,000 UAH
  ISO 14001 Certification Audit Preparation
  from 10,000 UAH
- ISO 45001 — Occupational Health & Safety
  Workplace Risk Assessment per ISO 45001
  from 12,000 UAH
  Occupational Health & Safety Documentation Development (ISO 45001)
  from 14,000 UAH
  ISO 45001 Requirements Staff Training
  from 7,500 UAH
  Occupational Safety Management System Internal Audit
  from 11,600 UAH
  ISO 45001 Certification Audit Preparation
  from 14,000 UAH
  Occupational Health & Safety Management System Certification (ISO 45001)
  from 35,000 UAH
- ISO 27001 — Information Security
  Enterprise Information Security Risk Analysis
  from 14,000 UAH
  Information Security Policy and Procedures Development
  from 17,000 UAH
  ISO 27001 Security Controls Implementation
  from 22,000 UAH
  ISMS Internal Audit (ISO 27001)
  from 15,000 UAH
  ISO 27001 Certification Audit Preparation
  from 17,000 UAH
  Information Security Management System Certification (ISO 27001)
  from 42,500 UAH
- ISO 50001 — Energy Management
  Enterprise Energy Audit
  from 14,000 UAH
  ISO 50001 Energy Policy and Objectives Development
  from 12,000 UAH
  Energy Consumption Monitoring System Implementation
  from 17,500 UAH
  ISO 50001 Internal Energy Audit
  from 11,500 UAH
  ISO 50001 Certification Audit Preparation
  from 14,000 UAH
  Energy Management System Certification (ISO 50001)
  from 35,000 UAH
- ISO 37001 — Anti-Bribery Management
  Organisational Bribery Risk Assessment (ISO 37001)
  from 11,500 UAH
  Anti-Bribery Policy and Procedures Development
  from 14,000 UAH
  ISO 37001 Anti-Bribery Procedures Staff Training
  from 7,500 UAH
  ISO 37001 Certification Audit Preparation
  from 14,000 UAH
  Anti-Bribery Management System Certification (ISO 37001)
  from 35,000 UAH
- ISO 22000 / HACCP — Food Safety
  HACCP System Development and Implementation
  from 22,500 UAH
  Food Production Hazard Analysis
  from 10,500 UAH
  HACCP and ISO 22000 Requirements Staff Training
  from 8,000 UAH
  HACCP / ISO 22000 Internal Audit
  from 12,500 UAH
  ISO 22000 Certification Audit Preparation
  from 14,000 UAH
  Food Safety Management System Certification (ISO 22000)
  from 35,000 UAH
- ISO 13485 — Medical Devices
  Medical Devices Regulatory Environment Requirements Analysis
  from 16,000 UAH
  ISO 13485 Quality System Documentation Development
  from 22,000 UAH
  Medical Device Manufacturing Process Validation
  from 21,500 UAH
  ISO 13485 Internal Audit
  from 14,000 UAH
  ISO 13485 Certification Audit Preparation
  from 22,500 UAH
  Medical Devices Quality Management System Certification (ISO 13485)
  from 50,000 UAH
Product Certification
- Electrical Equipment & Technology
  Low-Voltage Equipment Certification
  from 17,000 UAH
  Electronic Devices and Components Certification
  from 17,000 UAH
  Electromagnetic Compatibility (EMC) Testing
  from 14,000 UAH
  Declaration of Conformity for Electrical Equipment
  from 7,500 UAH
  Electrical Equipment Certification
  from 22,000 UAH
- Machinery & Equipment
  Machinery Risk Assessment
  from 15,000 UAH
  Technical File Development for Machinery
  from 11,500 UAH
  Declaration of Conformity for Machinery
  from 7,500 UAH
  Machinery and Equipment Certification
  from 27,500 UAH
- Construction Materials
  Construction Materials Laboratory Testing
  from 11,500 UAH
  Technical Certificate for Construction Products
  from 14,000 UAH
  Declaration of Conformity for Construction Materials
  from 7,500 UAH
  Construction Materials and Products Certification
  from 17,000 UAH
- Medical Devices
  Medical Devices State Register Registration in Ukraine
  from 31,000 UAH
  Medical Device Clinical Evaluation
  from 31,000 UAH
  Medical Device Technical Documentation
  from 21,500 UAH
  Medical Devices Declaration of Conformity
  from 11,500 UAH
  Medical Devices Certification in Ukraine
  from 42,500 UAH
- Personal Protective Equipment
  PPE Laboratory Testing
  from 11,500 UAH
  PPE Declaration of Conformity
  from 7,500 UAH
  Personal Protective Equipment (PPE) Certification
  from 17,000 UAH
- Children's Products & Toys
  Children's Clothing and Footwear Certification
  from 14,000 UAH
  Toys and Children's Products Laboratory Testing
  from 11,500 UAH
  Children's Products Declaration of Conformity
  from 7,500 UAH
  Children's Toys Certification
  from 18,000 UAH
- Food Products
  Sanitary and Epidemiological Examination of Food Products
  from 11,500 UAH
  Food Products Laboratory Analysis
  from 7,500 UAH
  Food Product Specifications and Labelling Development
  from 9,000 UAH
  Food Products Declaration of Conformity
  from 7,500 UAH
  Food Products Certification
  from 14,000 UAH
Technical Documentation
- Technical specifications (TS)
  Product Technical Specifications (TS) Development
  from 12,000 UAH
  Technical Specifications Registration
  from 7,500 UAH
  Technical Specifications Update and Amendment
  from 8,500 UAH
  Technical Specifications Compliance Verification
  from 8,500 UAH
- Hygienic and ecological conclusions
  Obtaining Sanitary and Epidemiological Conclusion
  from 11,500 UAH
  Environmental Impact Assessment (EIA)
  from 22,500 UAH
  Enterprise Environmental Certification
  from 17,000 UAH
  Waste Passports Approval
  from 10,000 UAH
- Conformity Documents
  Declaration of Conformity Preparation
  from 8,000 UAH
  Product Passports and Operating Instructions Development
  from 9,500 UAH
  Export Permissive Documentation Preparation
  from 15,000 UAH
  Product Certificate of Conformity Obtaining
  from 12,000 UAH
- Documentation Support
  Document Package Preparation for Regulatory Inspections
  from 12,000 UAH
  Interaction with State Authorities on Certification Matters
  from 10,000 UAH
  Pre-Scheduled Inspection Consultations
  from 10,000 UAH
  Recertification Process Support
  from 10,000 UAH
Permissive Documentation
- Business Licensing
  Licence Reissuance and Renewal
  from 12,000 UAH
  Business Licensing Consultations
  from 5,000 UAH
  Licensing of Specific Types of Business Activity
  from 15,500 UAH
- High-Risk Permits
  High-Risk Works Performance Permit
  from 15,200 UAH
  Facility Safety Declaration Registration
  from 18,800 UAH
  High-Risk Equipment Operation Permit
  from 14,800 UAH
- Export Documentation
  Certificate of Origin Obtaining
  from 4,500 UAH
  Export Documents Legalisation and Apostille
  from 7,500 UAH
  Product Export Documentation Preparation
  from 11,500 UAH
Audits & Expertises
- Compliance Audits
  Enterprise Management System Internal Audit
  from 11,500 UAH
  Enterprise Certification Readiness Audit
  from 12,000 UAH
  Supplier Compliance Audit
  from 15,000 UAH
  Independent Standards Compliance Audit
  from 18,000 UAH
- Technical Expertises
  Equipment and Machinery Technical Expertise
  from 15,800 UAH
  Enterprise Energy Audit
  from 19,200 UAH
  Technical Documentation Expert Assessment
  from 13,000 UAH
- Laboratory Research
  Workplace Environmental Factors Measurement
  from 12,500 UAH
  Laboratory and Testing Centre Accreditation
  from 21,000 UAH
  Product Laboratory Testing
  from 8,500 UAH
Tender Certification
- Tender Preparation
  Tender Documentation Certification Requirements Analysis
  from 8,500 UAH
  Tender Supporting Document Package Formation
  from 10,500 UAH
  Certificate and Document Preparation for Tender Participation
  from 12,000 UAH
- Tender Procedure Support
  Urgent Certificate Processing for Tender
  from 19,000 UAH
  Document Compliance Verification Against Tender Requirements
  from 8,800 UAH
  Tender Certification Requirements Consultations
  from 4,400 UAH

ISO 13485 — Medical Devices in Ukraine: 66427 specialists

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