Services

Service #1

Service #1

Service #1

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Acting as the Local Authorised Representative (LAR) for medical device registration in Malaysia according to Malaysia Medical Device Act 2012, Medical Device Regulation 2012 (see https://www.mda.gov.my/doc-list/legislation.html) and relevant Guidance Documents (https://www.mda.gov.my/doc-list/guidance-document.html)

Service #2

Service #1

Service #1

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Providing EU MDR (Regulation (EU) 2017/745) related consulting services in particular regarding Technical Documentation / Medical File and Quality Management System Compliance

Helpful Links

European Commission Medical Device Regulation

European Commission Medical Device Regulation

European Commission Medical Device Regulation

Medical device Coordination Group (MDCG)

European Commission Medical Device Regulation

European Commission Medical Device Regulation

MEDDEV Guidance Documents

European Commission Medical Device Regulation

International Medical Device Regulators Forum (IMDRF)

International Medical Device Regulators Forum (IMDRF)

International Medical Device Regulators Forum (IMDRF)

International Medical Device Regulators Forum (IMDRF)

MDR designated Notified Bodies

International Medical Device Regulators Forum (IMDRF)

Notified Bodies Operations Group (NBOG)

Notified Bodies Operations Group (NBOG)

International Medical Device Regulators Forum (IMDRF)

Notified Bodies Operations Group (NBOG)