2A, Jalan Astana 1D, Bandar Bukit Raja, 41050 Klang, Selangor

+603-3884 7813

Medical Devices courses offered by Kiwa

Medical Devices Courses

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Medical Devices

MS2058:2018 Good Engineering Maintenance Management of Active Medical Devices

This course is established to provide industrial support through competent regulatory training to industry, user and other authority for achieving requirements of Medical Device Act (Act 737) and Medical Device Regulation 2012 (MDR 2012).
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Medical Devices

ISO 13485:2016 Medical Devices Management System Lead Implementer Course (certified by Exemplar Global)

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Medical Devices

ISO 13485:2016 Medical Devices Management System Lead Auditor Course (certified by Exemplar Global)

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Medical Devices

GDPMD Requirements (certified by Exemplar Global)

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Medical Devices

ISO 14971 Medical Devices Risk Assesment (certified by Exemplar Global)

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Medical Devices

GDPMD Internal Auditor Course (certified by Exemplar Global)

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Medical Devices

ISO 13485:2016 Medical Devices Requirements (certified by Exemplar Clobal)

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Medical Devices

ISO 13485:2016 Internal Auditor Course (certified by Exemplar Global)

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Medical Devices

Validation For Medical Device - IQ,OQ,PQ

The training provides: • Familiarize with the latest FDA guidelines and interpretations of product/process validation. • Recognize how Validation Master Plans help the planning process. • Differentiate between qualification, verification and validation. • Identify if (and when) validations are required. • Determine what activities must be completed prior to conducting a validation (confirming) event. • Learn how to conduct and document a validation event. • Understand what to do when things go wrong (What if's!). • Use peer feedback to learn about your own planned or completed validation programs including specific issues and questions.

Kiwa International Certifications(M) Sdn Bhd

2A, Jalan Astana 1D, Bandar Bukit Raja, 41050 Klang, Selangor

+603-3884 7813

info@kiwacert.com

Accredited to ISO/IC 17021:2015

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ACB QMS 28

ACB OSH 17

ACB EMS 20

ACB GMP 06

ACB FSMS 13

ACB HACCP 08

ACB MDMS 05

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2022 © Kiwa International Certifications (M) Sdn Bhd. ALL Rights Reserved.

Kiwa International Certifications(M) Sdn Bhd

2A, Jalan Astana 1D, Bandar Bukit Raja, 41050 Klang, Selangor

+603-3884 7813

info@kiwacert.com

Accredited to ISO/IC 17021:2015

A Simple Image
A Simple Image

ACB QMS 28

ACB OSH 17

ACB EMS 20

ACB GMP 06

ACB FSMS 13

ACB HACCP 08

ACB MDMS 05

A Simple Image
A Simple Image
2022 © Kiwa International Certifications (M) Sdn Bhd. ALL Rights Reserved.