Consultation and Training in Medical Devices

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

Friday

PERSIJILAN ISO 13485:2003 DAN GDPMD



Pada Februari 2012, Akta Barangan Perubatan 2012 telah di "Gazette"kan,dan ini bermakna kesemua syarikat berkaitan barangan perubatan (Pengilang, Pengimpot dan Pengedar) adalah WAJIB untuk mendapatkan persijilan samada ISO 13485:2003 atau GDPMD (Good Distributor Practice for Medical Device).

Jika anda mengendalikan perniagaan seperti di atas, sila hubungi kami untuk mendapat penerangan lebih lanjut berkenaan khidmat nasihat berkaitan persijilan dan penerangan-penerangan berkenaan proses-proses penguatkuasaan oleh Kementerian Kesihatan Malaysia (MOH) di bawah seliaan Jabatan Barangan Perubatan, Putrajaya.


Monday

PROGRAM LATIHAN MARA



Berita baik kepada semua syarikat milikan bumiputera.

MARA (Majlis Amanah Rakyat) telah menyediakan kemudahan untuk syarikat-syarikat bumiputera yang memerlukan pekerja-pekerja diberikan latihan berkaitan kerja dan perlaksanaan syarikat.

Latihan-latihan yang dibenarkan:
1. Latihan berkaitan keperluan-keperluan ISO 9001, ISO 14001, ISO 18000 dan seumpamanya.

2. Latihan kemahiran-kemahiran berkaitan perkhidmatan dan barangan yang diniagakan seperti pengurusan stor, pengurusan kewangan dsb,

3. Latihan berkaitan motivasi dan kepimpinan,

4. Latihan-latihan yang memberikan impak kepada perkhidmatan dan pengeluaran syarikat.

Syarat-syarat layak:
1. Mestilah syarikat milikan bumiputera.

2. Para pekerja yang dicadangkan perlu dalam caruman KWSP.

3. Peserta sekurang-kurangnya 5 (lima) orang setiap syarikat.

4. Sekurang-kurangnya 25 orang peserta dalam satu program latihan.


Pakej latihan (ditanggung):
1. Latihan selama sekurang-kurangnya 2 hari satu malam atau 3 hari dua malam.

2. Penginapan disediakan berhampiran tempat kursus (hotel).

3. Makan dan minum (pagi, tengahari dan petang)
.
4. Barangan latihan.


Perkara tidak ditanggung:
1. Kenderaan untuk  pergi dan balik tempat kursus.

2. Kos “parking” , minyak dan tol.


SILA HUBUNGI 017-2130501 - AZRIN
untuk penerangan selanjutnya.


*

Tuesday

Jawatan Kosong

Agen kawasan diperlukan untuk "introduce"/ promosi program konsultansi dan training kami di kawasan anda (seluruh Malaysia, termasuk Sabah dan Serawak).

Target adalah syarikat-syarikat swasta bumiputera/ bukan bumiputera.

Bidang: -  tiada limit bidang.

Komiyen lumayan menanti anda.

Sila hubungi 017-2130501 - Azrin

Thursday

LATEST NEWS!!

Ummah Synergy will conduct a public training on Risk Management Analysis (ISO 14971) and Introduction to Sterilization Validation Requirements for Medical Device.

A comprehensive training shall focus to:
1. Elaborate on Risk management analysis requirements
2. Understanding of standard requirements
3. Steps towards implementation and data analysis.
4. System documentation development
5. Arrangement of product prior for sterilization
6. Microbiological control and analysis
7. Analysis of data
8. Development of standard reporting

Program
Training shall be conducted for 2 days.

Venue
To be advice

Cost
RM885.00 for 2 days training (including beverages)

Please call 012-2988502 or 017-2130501 (Azrin for Booking)

Friday


WELCOME TO UMMAH SYNERGY GROUP OF COMPANY
ABOUT US

UMMAH SYNERGY VENTURES is a professional training and consulting company, offering systematic approaches to improve quality and effectiveness of the system and enhance the productivity. Teamed with highly experience personnel from many years of manufacturing environment and multi tasking capability, UMMAH SYNERGY is highly competent to assist, guide and facilitate customer, not only for quality system implementation, but also able to assist manufacturing and operation management.  

In today’s corporate world of economic wars, 
“QUALITY” is the most powerful weapon to gain foothold & survive. Certification of Management System gives National and International recognition to the organizations effort towards Customer Satisfaction and enhances its image in the corporate market.  
Our AIM is to to provide Total Solution for Quality System Implementation and Training Services and  also committed to offer great value of quality services to Customer and  to maintain professionalism and trustworthy.


OUR LOCATION

UMMAH SYNERGY VENTURES is located at
No.17-1, Jalan Opera D, U2/D , Taman TTDI Jaya, 40150, Shah Alam, Selangor Darul Ehsan.

Tel: 603-7832 3502 / 4502,  Fax: 03-7831 8502 HP: 017-213 0501 (En.Azrin Affendi)
016-688 0744 (En.Yusri)

OUR SCOPE

UMMAH SYNERGY VENTURES specialize in Consultancy and Training for ISO 9001, ISO 13485, TS 16949, ISO 14001, OHSAS 18001 & ISO 22000 HACCP Certification, CE Marking, Lean Manufacturing, Sterilization Validation, GDPMD, CE Marking, Kaizen, and 5S Implementation.





Our prime expertise are Medical Devices and Environmental Safety Standard Requirement. Notwithstanding, all the ISO standard requirements as per stated above.


OUR COVERAGE

UMMAH SYNERGY VENTURES operates throughout the whole Malaysia needs for consultation services including Sabah and Sarawak. We have the complete range of consultation expertise and man power to cover the market needs.

Why Choose UMMAH SYNERGY

  • Innovative and comprehensive solutions
  • Conduct strict moral, ethical and legal code
  • We have long-term relationships with our clients
  • We have the experience, expertise and proven track record
  • Use of proven powerful techniques to enhance customer processes in all respects
  • Network of Overseas Strategic Partners
  • Industry Experienced Consultation Team
  • Competitive Quotations
  • Long term monitoring and assistance


BUSINESS ADVICE

Through the use of intelligent applications and technologies for gathering, providing access to, and analyzing data we help enterprise users make better business decisions. With comprehensive knowledge of all of the factors that may affect your business and your customers, competitors, business partners, economic environment, and internal operations, we help our clients make effective and measurable business decisions.

We trust that our business advice shall enable our clients to make such important decisions imperative and indispensable to the growth of your company. UMMAH SYNERGY helps companies to find their unique value proposition and ways to maximize it through organic growth, partnerships, or acquisition, with the help of our expert valuable research and customer feedbacks. UMMAH SYNERGY will guide your organization to new heights and formulate a strategy to achieve your business goals.