Ummah Synergy Resourses boleh membantu anda yang perlukan bantuan konsultansi untuk pendaftaran syarikat barangan medikal dan juga pendaftaran barangan medikal mengikut keperluan Akta Barangan Perubatan 2013.
Sila hubungi kami untuk mendapatkan keterangan lanjut.
Untuk syarikat bumiputera, kemudahan GERAN boleh diusahakan.
Product Line ISO
Saturday
Thursday
Medical Evaluation
Clinical Evaluation is a form of clinical study to evaluate the conformity of medical devices of it safety and performance as per intended purpose.
The requirement of the Clinical Evaluation has been clearly stated in the Clinical Evaluation guideline such as MEDDEV 2.7.1, MEDDEV 1.12 and ISO 14155 which are the standard and guidance for the documentation and reporting requirements.
Clinical evaluation need to be carried out for all the medical device, regardless of the classification and risk associate. The current development in the EU regulatory had emphasis on a few medical device related requirements to be enforce such as the proper Clinical Study of Pre and Post Market. The focus was streamlined as there are an increase number of faulty medical devices in the EU market and the study had shown that the lack of proper Clinical Evaluation and study is one of the main factor that cause the incompetent devices being introduce in the market such as the EU.
Looking into these scenario, the Ministry of Health had impose its Medical Device Act, 737 starting February 2012 and finally start the implementation dated 1th July 2013. The requirement of companies not only to certify with either ISO 13485 or GDPMD, they also need show the prove of product safety and performance had been made by collating the Technical File or in this case, is called CSDT (Common Submission Dossier Template).
To get more information regarding the above, Kindly contact 017-2130501 Azrin to get more detail and explanation.
The requirement of the Clinical Evaluation has been clearly stated in the Clinical Evaluation guideline such as MEDDEV 2.7.1, MEDDEV 1.12 and ISO 14155 which are the standard and guidance for the documentation and reporting requirements.
Clinical evaluation need to be carried out for all the medical device, regardless of the classification and risk associate. The current development in the EU regulatory had emphasis on a few medical device related requirements to be enforce such as the proper Clinical Study of Pre and Post Market. The focus was streamlined as there are an increase number of faulty medical devices in the EU market and the study had shown that the lack of proper Clinical Evaluation and study is one of the main factor that cause the incompetent devices being introduce in the market such as the EU.
Looking into these scenario, the Ministry of Health had impose its Medical Device Act, 737 starting February 2012 and finally start the implementation dated 1th July 2013. The requirement of companies not only to certify with either ISO 13485 or GDPMD, they also need show the prove of product safety and performance had been made by collating the Technical File or in this case, is called CSDT (Common Submission Dossier Template).
To get more information regarding the above, Kindly contact 017-2130501 Azrin to get more detail and explanation.
Monday
IMPORTANT ANNOUNCEMENT!
Please be inform that UMMAH SYNERGY RESOURCES does not have any ASSOCIATION what so ever, with UMMAH SYNERGY CORPORATION.
We shall not be subjected to any liability and to any legal claim deriving from any negligence and/or misconduct act/advice/conduct produced or caused by any UMMAH SYNERGY CORPORATION personnel or any third party appointed by UMMAH SYNERGY CORPORATION.
For more information, kindly call 017-2130501.
- ADMIN -
Subscribe to:
Posts (Atom)