Product Line ISO
Monday
Thursday
SEMINAR ON REGISTRATION OF MEDICAL DEVICE
SEMINAR ON REGISTRATION OF MEDICAL DEVICES
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Registration of Medical Device is mandatory base on Medical Device Act 737, 2012.
Part II, registration of medical device and conformity assessment body
“Requirement for Registration of medical device
Part 5 (1) No medical device shall be imported, exported or placed in the market unless the medical device is registered under this Act.”
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Overview:
Medical device product registration had been a hot topic among the stake holder ever since the Medical Device Act 737, gazetted and its requirement for all medical device related supplier or importer to register.
It had been a concern on the safety and performance of medical device being used and already widely circulated in the country.
Since no act had governing the supply and activity regarding the medical devices supply chain, registration of medical device will be a move to ensure all medical device being circulated and distributed in the country had undergone strict evaluation and monitoring, especially from the regulatory body, MDA.
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The Topics:
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Speaker:
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Who Should attend:
Target audience: 100 pax
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Date and Time:
Date: 15/8/2015 Time: 9.30am - 1.00pm
Duration: 1/2 day
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Location:
Ballroom, Hotel, Shah Alam
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Fee: RM 168 per pax.
E- mail your enquiry to:
sales.ummahsynergy@gmail.com @ booking at 03 7831 8502 (IZA)
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Tuesday
PROGRAM PEMBANGUNAN USAHAWAN
TAHUKAH ANDA TERDAPAT BEBERAPA PROGRAM KERAJAAN DAN SWASTA UNTUK MEMBANTU SYARIKAT-SYARIKAT MULA BERNIAGA?
sila klik link dibawah.
Program Kerajaan/ Berkanun
Program Swasta
sila klik link dibawah.
Program Kerajaan/ Berkanun
| No. | Program | Agensi |
| 1. | Skim Prosper Usahawan Muda | PUNB |
| 2. | Dana Usahawan Muda | SMEBNK |
| 3. | Yayasan Pembangunan Usahawan Terengganu | YPU |
| 4. | Skim Pembiayaan Ekonomi Desa (SPED) | KKLW |
| 5. | Skim Permulaan Usahawan Bumiputera | TERAJU |
| 6. | Modal Usahawan 1 Malaysia | AGROBNK |
| 7. | Program Bimbingan Usahawan | FAMA |
Program Swasta
| No. | Program | Syarikat |
| 1. | Usahawan.com | Usahawan.com |
| 2. | Klinik Usahawan | AzizanOthman |
| 3. | Persatuan Usahawan Internet Malaysia | PUIM |
| 4. | Akademi Perintis Usahawan Muda | ODC2U |
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GDPMD CERTIFICATION PROCESS FLOW
Gap Analysis
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GDPMD Awareness Training
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GDPMD RCM preparation
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GDPMD Procedures preparation
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GDPMD Forms preparation
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Identification of related mandatory documentations
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Final review of documents
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Internal Audit Training
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Internal Audit Workshop
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Actual Internal Audit Program
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Management Review Meeting
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1st Stage Certification Audit - by CAB
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2nd Stage Certification Audit - by CAB
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Certification Issuance - by CAB
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Medcast Registration
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MDA review
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Establishment License Issuance - by MDA
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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).
ETO VALIDATION AS PER ISO 11135 Requirements for the development, validation and routine control of a sterilization process for medical devices
Do you have your own ETO sterilization Chamber or Do you plan to purchase any? Have you think of the validation requirement for the ETO sterilization process?
Validation of ETO sterilizer is deem mandatory and compulsory to ensure assurance of sterilization of good being evaluated and verified in accordance to the designated manual.
Some of the requirements for the validation are the pre validation requirements which cover the product condition, packaging specification, measuring tools and many more.
One need to ensure the component of the validation requirements being fulfilled.
a. Installation Qualification
b. Operational Qualification
c. Performance Qualification - Physical
d. Performance Qualification - Microbiological
During all of these stages, validation shall cover the requirements for machine (ETO) installation and operational conformance to the intended use. Evaluation of Bio Indicator to be use during the process need to be carry out to ensure accuracy, dependable, reliability and meeting the specification for ETO process. Identification of lethal cycle or Half cycle identification which will mark the final dwell time requirements for full cycle of successful sterilization process.
Need to know more information regarding the ISO 11135 (now 2014) Sterilization of health-care products - Ethylene
oxide - Requirements for the development, validation and routine
control of a sterilization process for medical devices
Contact us now!
Dapatkan sistem ISO 9001 dalam masa kurang 5 bulan ?
Tahukah anda bahawa sistem ISO 9001 boleh diperolehi dalam masa yang singkat jika anda tahu caranya?
ISO 9001 adalah sistem pengurusan berkualiti yang menekankan keperluan memenuhi spesifikasi dari manual ISO 9001 terbaru dan implementasi sistem yang telah dibuat. Selain itu, keperluan juga adalah untuk sistem itu di audit oleh pihak ketiga atau dinamakan badan persijilan yang terpilih.
Sistem ISO 9001 adalah sebenarnya, sistem tambahan yang membantu memperbaiki sistem syarikat sedia-ada supaya mengikut satu "acuan" perlaksanaan sistem syarikat yang menyamai standard syarikat-syarikat ber ISO yang lain dan dengan ini membuatkan pengurusan menjadi seragam dan mudah dikawal selia.
Sistem-sistem yang dibentuk akan menyebabkan secara tidak langsung:
a. Kawalan kualiti kerja
b. Pematuhan kepada keperluan pelanggan
c. Penambahbaikan berlaku dalam operasi syarikat
d. Pengenal pastian masalah-masalah dalam syarikat dan mendapatkan cara-cara penyelesaian
e. Peningkatan kualiti kerja kepada pekerja-pekerja syarikat
f. Peningkatan kesedaran kepada keperluan kepuasan pelanggan
Sistem ISO 9001 adalah sangat berguna dalam jangka masa panjang dalam menjadikan perubahan-perubahan positif dan pemantauan kepada keperluan pembaikan dalam mutu sistem sesuatu syarikat yang akhirnya akan dapat membantu peningkatan kualiti barangan dan juga perkhidmatan.
Di bawah adalah skop manual ISO 9001:2008
Syarikat anda perlukan persijilan ISO 9001? Sila hubungi kami 03-7832 3502 Ummah Synergy Resource, TTDI Jaya, Shah Alam.
ISO 9001 adalah sistem pengurusan berkualiti yang menekankan keperluan memenuhi spesifikasi dari manual ISO 9001 terbaru dan implementasi sistem yang telah dibuat. Selain itu, keperluan juga adalah untuk sistem itu di audit oleh pihak ketiga atau dinamakan badan persijilan yang terpilih.
Sistem ISO 9001 adalah sebenarnya, sistem tambahan yang membantu memperbaiki sistem syarikat sedia-ada supaya mengikut satu "acuan" perlaksanaan sistem syarikat yang menyamai standard syarikat-syarikat ber ISO yang lain dan dengan ini membuatkan pengurusan menjadi seragam dan mudah dikawal selia.
Sistem-sistem yang dibentuk akan menyebabkan secara tidak langsung:
a. Kawalan kualiti kerja
b. Pematuhan kepada keperluan pelanggan
c. Penambahbaikan berlaku dalam operasi syarikat
d. Pengenal pastian masalah-masalah dalam syarikat dan mendapatkan cara-cara penyelesaian
e. Peningkatan kualiti kerja kepada pekerja-pekerja syarikat
f. Peningkatan kesedaran kepada keperluan kepuasan pelanggan
Sistem ISO 9001 adalah sangat berguna dalam jangka masa panjang dalam menjadikan perubahan-perubahan positif dan pemantauan kepada keperluan pembaikan dalam mutu sistem sesuatu syarikat yang akhirnya akan dapat membantu peningkatan kualiti barangan dan juga perkhidmatan.
Di bawah adalah skop manual ISO 9001:2008
| 0.0 Foreward |
Syarikat anda perlukan persijilan ISO 9001? Sila hubungi kami 03-7832 3502 Ummah Synergy Resource, TTDI Jaya, Shah Alam.
Sunday
GDPMD AND PRODUCT REGISTRATION
GDPMD Certification, Establishment License and Product registration are two regulatory requirements for Medical Device Industry player. Started from July 2012 until closing date July 2015, all company affected required to ensure fulfillment of the said requirement or potentially face legal action base on the requirements of Medical Device Act 737.
GDPMD Certification is a design of system that designated for medical device distribution supply chain to ensure product safety and performance of devices throughout the distribution cycle.
Apart from that, the GDPMD will also ensure the company involved shall retain the necessary procedures and protocol of pre and post sales activity.
GDPMD will also help to ensure of prevention of counterfeit adulterate, unwholesome and tampered medical devices being supplied within the same supply chain. This will ensure only good products are supplied to end users.
For LAR (Local Authorised Representative), the additional requirement for the compliance of GDPMD will be the Product Registration of devices.
Product Registration will involve of the company to fulfill the Conformity Assessment such as the technical product summary by compiling technical file and producing the technical summary called the CSDT (Common Submission Dossier Template).
CSDT is a compiled of technical information, in a summary form, base on the designated CSDT documents requirement of Medical Device Authority of Malaysia and must be submitted for Product Evaluation by CAB.
For more information of the above, Kindly contact us at 03 7832 3502/4502 Ummah Synergy Resources.
GDPMD Certification is a design of system that designated for medical device distribution supply chain to ensure product safety and performance of devices throughout the distribution cycle.
Apart from that, the GDPMD will also ensure the company involved shall retain the necessary procedures and protocol of pre and post sales activity.
GDPMD will also help to ensure of prevention of counterfeit adulterate, unwholesome and tampered medical devices being supplied within the same supply chain. This will ensure only good products are supplied to end users.
For LAR (Local Authorised Representative), the additional requirement for the compliance of GDPMD will be the Product Registration of devices.
Product Registration will involve of the company to fulfill the Conformity Assessment such as the technical product summary by compiling technical file and producing the technical summary called the CSDT (Common Submission Dossier Template).
CSDT is a compiled of technical information, in a summary form, base on the designated CSDT documents requirement of Medical Device Authority of Malaysia and must be submitted for Product Evaluation by CAB.
For more information of the above, Kindly contact us at 03 7832 3502/4502 Ummah Synergy Resources.
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