Consultation and Training in Medical Devices

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

Monday

MDA HELPDESK LINK

HELPDESK is a medium created by MDA to ease communication regarding various technical matter related to MDA requirement and registration.

Similar to messaging, its create "ticket" as communication password to a dedicated communication matter.

Click link below to enter.

HELPDESK
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Sunday

MDA REGISTERED MEDICAL DEVICE LINK


Anda ingin mendaftar barangan perubatan? Rujuk senarai barangan telah didaftar dari link dibawah untuk rujukan:

1. Klasifikasi barangan medikal
2. Rule klasifikasi
3. Senarai produk dan syarikat yang dilantik

Klik di bawah:
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Wednesday

UPGRADE KE ISO 9001:2015



Kami dari syarikat perundingan ISO QMS berpusat di Shah Alam , Selangor menyediakan perkhidmatan "UPGRADE QMS ISO 9001:2008 kepada ISO 9001:2015".

Tempoh diperlukan untuk menyiapkan kerja-kerja update adalah 5 - 7 hari bekerja dan melibatkan:

1. Latihan "awareness" ISO 9001:2015 - 1 hari
2. Latihan pengurusan risiko (Risk Management) - 1 hari
3. Bengkel penilaian dan penyediaan dokumentasi - 1 hari
4. Bengkel audit dalaman dan perlaksanaan - 1 hari


Lain-lain perkhidmat kami:
1. Pendaftaran Barangan Perubatan (Geran untuk yang layak)
2. Konsultansi persijilan GDPMD (Geran untuk yang layak)
3. Konsultansi persijilan ISO 9001 ( syarat pembiayaan 50%)


Nota: semua di atas tidak termasuk kos persijilan.



Sila hubungi no: 03-78323502/4502 @ e mail ke sales.ummahsynergy@gmail.com
@ lawati website kami di: ummahsynergy.blogspot.com


Admin
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Sunday

Technical Advice

In conjunction with collaboration arrangement of Ummah Synergy Ventures with Steinbeis Foundation Malaysia, we invite any company/ SME looking for answer for their technical, certification and product related problem to contact us and arrange for appointment in order to book consultation session.


Area of expertise:
1. Certification requirement of any ISO or any related quality management system.


2. Product design and development program.


3. Statutory and Regulatory requirement.


4. Registration of product and conformity assessment.


5. Inspection and  testing requirements and facilitation.
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MALAYSIA STEINBEIS FOUNDATION: ONE ON ONE CONSULTANCY PROGRAMME (GRANT)



"CLICK FOR ONLINE FORM"



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Saturday

MDA PRODUCT REGISTRATION TRAINING (MEDICAL DEVICES)


TITLE: MEDICAL DEVICE REGISTRATION PROCESS COACHING
DATE: DAILY
DURATION: 1 DAY
VENUE: TTDI JAYA, SHAH ALAM
PRICE:

RM 5,000.00 PER DAY - MAX 10 PAX - (company)
@
RM 1,500.00 PER DAY/ PER PAX - (Individual coaching)

PLEASE CALL: 03-7832 3502
017-2130501 (Whatsapp)

Or Click online form (HERE)
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TRAINING PROGRAM 2017 - 2018



TITLE: UPGRADE OF ISO 9001:2008 TO ISO 9001:2015
DATE: EVERY SATURDAY & SUNDAY
DURATION: 1 @ 2 DAYS
VENUE: TTDI JAYA, SHAH ALAM
QA MANAGER, HR MANAGER, EXECUTIVES, CEO, DIRECTORS
ITINERARY:
  1. ISO 9001:2015 AWARENESS TRAINING
    1. IDENTIFICATION OF CONTEXT AND INTERESTED PARTY
    2. THE MAJOR CHANGES
    3. UNDERSTANDING DOCUMENT REQUIREMENTS
    4. RISK MANAGEMENT REQUIREMENTS

  1. RISK BASE MANAGEMENT TRAINING (OPTIONAL)
    1. UNDERSTANDING RIS BASE CONCEPT
    2. PROCEDURE FOR RISK MANAGEMENT
    3. USE OF RISK MANAGEMENT TECHNIQUE
CHARGES:
PACKAGE 1:
ISO 9001:2015 AWARENESS TRAINING ONLY
= RM 580/ PAX

PAKAGE 2:
ISO 9001:2015 & RISK MANAGEMENT TRAINING
= RM 1000/ PAX
KINDLY CONTACT US AT 03 - 7832 3502/ 017-2130501 (WHATSAPP)
OR E MAIL AT: sales.ummahsynergy@gmail.com

@ FILL UP THIS ONLINE FORM (CLIK HERE)




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