Consultation and Training in Medical Devices

Expert in ISO 13485, GDPMD, MDA Regulatory Requirements, CE marking, FDA related and Medical Device Related Requirements

Tuesday

GDPMD CERTIFICATION PROCESS FLOW


Gap Analysis

GDPMD Awareness Training

GDPMD RCM preparation

GDPMD Procedures preparation

GDPMD Forms preparation

Identification of related mandatory documentations

Final review of documents

Internal Audit Training

Internal Audit Workshop

Actual Internal Audit Program

Management Review Meeting

1st Stage Certification Audit - by CAB

2nd Stage Certification Audit - by CAB

Certification Issuance - by CAB

Medcast Registration

MDA review

Establishment License Issuance - by MDA



Note: Implementation of system shall be carry out concurrent with the system development and update.

Duration of each consultation and GPDMD system development processes will be varies base on :
a. Complexity of processes
b. Number for premises involved
c. Application for secondary assembly requirements
d. Type of devices involved
e. Type of GDPMD applied (LAR, Distributor, Importer and Service provider).