Quality Assurance & Global Compliance

Certifications & Accreditations

Medi Waves Inc is committed to international quality benchmarks, patient safety regulations, and environmental excellence across our complete range of hospital and medical equipment.

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ISO 13485
Medical Device QMS
CE Marked
European Safety Directives
WHO GMP
Good Manufacturing Practice
8+
International Accreditations
ISO 13485:2016 Certificate - Medi Waves Inc
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Medical Device Quality Standard

ISO 13485:2016 Certification

Medical Device Quality Management System covering the design, manufacture, installation, and servicing of active medical equipment, infant warmers, phototherapy, electrosurgery units, and patient monitoring systems.

  • Certificate Number: BN23110/22239 | Rev. 00
  • Accreditation Body: BSCIC Certifications / NABCB QM 030 & IAF MLA
  • Validity Period: 11-Oct-2024 to 10-Oct-2027
ISO 9001:2015 Certificate - Medi Waves Inc
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Global Quality Benchmark

ISO 9001:2015 Certification

Internationally certified Quality Management System guaranteeing end-to-end consistency, systematic inspection, and premium manufacturing standards from design through healthcare facility delivery.

  • Certificate Number: BN23205/22238 | Rev. 00
  • Accreditation Body: BSCIC Certifications / NABCB QM 030 & IAF Scope: 19, 23, 29
  • Validity Period: 11-Oct-2024 to 10-Oct-2027
CE Compliance Certification - Medi Waves Inc
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European Union Directive

CE Compliance Certification

Official conformity declaration under Medical Devices Directive (93/42/EEC) validating our hospital equipment, infant care solutions, surgical diathermy, and monitoring equipment for global and European distribution.

  • Certificate Number: CE/25M05173
  • Auditing Body: MQA Certification Services / UKAF CERT LIMITED, London, UK
  • Directive: Medical Devices Directive (93/42/EEC) Class II Safety Directives
ISO 14001:2015 Certificate - Medi Waves Inc
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Environmental Sustainability

ISO 14001:2015 Certification

Environmental Management System certification validating sustainable, eco-responsible manufacturing processes, resource optimization, waste mitigation, and clean production practices across all manufacturing facilities.

  • Certificate Number: MIEM2603161
  • Accreditation Body: Deutsche Accreditation Board (DAB), Muenchen, Germany
  • Validity Period: 01/04/2026 to 31/03/2029
ISO 45001:2018 Certificate - Medi Waves Inc
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Workplace Health & Safety

ISO 45001:2018 Certification

Occupational Health and Safety Management System ensuring rigorous workplace safety protocols, proactive hazard prevention, and optimal employee welfare standards throughout medical manufacturing plants.

  • Certificate Number: MIOH2603162
  • Accreditation Body: Deutsche Accreditation Board (DAB), Muenchen, Germany
  • Validity Period: 01/04/2026 to 31/03/2029
ISO 50001:2018 Certificate QRO - Medi Waves Inc
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Energy Efficiency & Optimization

ISO 50001:2018 Certification (QRO)

Energy Management System certification acknowledging continuous energy performance optimization, efficient industrial power utilization, and low-carbon medical equipment assembly.

  • Certificate Number: 305026081883EN
  • Accreditation: QRO Certification / EGAC & IAF Multilateral Arrangement
  • Validity Period: 18th August 2026 to 17th August 2029
ISO 50001:2018 Certificate DAB - Medi Waves Inc
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Energy Management Systems

ISO 50001:2018 Certification (DAB)

Accreditation through the Deutsche Accreditation Board validating energy management protocols, sustainable electrical consumption, and equipment efficiency in medical manufacturing.

  • Certificate Number: MI25010057
  • Accreditation Body: Deutsche Accreditation Board (DAB), Muenchen, Germany
  • Validity Period: 13/10/2025 to 12/10/2028
WHO-GMP Compliance Certificate - Medi Waves Inc
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Good Manufacturing Practice

WHO-GMP Compliance

Validation confirming that our manufacturing premises, cleanroom environments, personnel hygiene, equipment calibration, and testing laboratories fully comply with World Health Organization Good Manufacturing Practices.

  • Certificate Number: MIGMP2601145
  • Accreditation Body: Deutsche Accreditation Board (DAB), Muenchen, Germany
  • Validity Period: 24/02/2026 to 23/02/2029

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