GDPMD @ ISO 13485 CONSULTANCY AND TRAINING

Thursday

SEMINAR ON REGISTRATION OF MEDICAL DEVICE

SEMINAR ON REGISTRATION OF MEDICAL DEVICES

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.”

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.

The Topics:

To make awareness of the registration approach
Understanding the documentation requirement
Compliance with product safety and performance
Understanding CAB assessment requirements
Consequences of product sold without registration
The Fast Tract approach.

Speaker:

MDA official (To be advice)
CAB representative
TBA

Who Should attend:

Medical Device LAR
Medical device Importer
Medical Device distributor
Medical Device Manufacturer

Target audience: 100 pax

Date and Time:

Date: 15/8/2015 Time: 9.30am - 1.00pm

Duration: 1/2 day

Location:

Ballroom, Hotel, Shah Alam

Fee: RM 168 per pax.

E- mail your enquiry to:

sales.ummahsynergy@gmail.com @ booking at 03 7831 8502 (IZA)

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

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

Application for GRANT?

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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).

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

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.