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Unser Solutions Pte LtdWe work with companies to meet regulatory requirements for medical devices. Unser Solutions Pte Ltd.
http://www.unser.biz/
We work with companies to meet regulatory requirements for medical devices. Unser Solutions Pte Ltd.
http://www.unser.biz/
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Unser Solutions Pte Ltd | unser.biz Reviews
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We work with companies to meet regulatory requirements for medical devices. Unser Solutions Pte Ltd.
unser.biz
Unser Solutions Pte Ltd - Service
http://www.unser.biz/service1.html
A sound regulatory strategy is a key starting point for medical device manufacturers. Designed to provide your organisation with an understanding of specific regulatory requirements in chosen target markets, a Regulatory Strategy Report is your road map to market. The Regulatory Strategy Report includes:. Device classification in chosen regions/markets. Applicable conformity assessment routes in chosen regions/markets. Identification of applicable harmonised standards. Recommended road map to market.
Unser Solutions Pte Ltd - Service
http://www.unser.biz/service3.html
Many countries require medical devices to be registered prior to placement on market. Many more countries are implementing new legislation and regulations that will require product registration or licensing. Product registration process varies from country to country, so does the registration requirements. We can assist you and/or your distributors to:. Prepare the necessary technical documentation for submission. Follow through supplementary request from regulatory agency. Unser Solutions Pte Ltd.
Unser Solutions Pte Ltd - Services
http://www.unser.biz/service4.html
In many countries, post-market requirements are mandated by legalisation and regulations. If you don't have a post-market surveillance system set up, we can assist to help you set up a system that is appropriate for your company. Call or email us today to ask for an assessment meeting:. Or if you prefer, send us a quick message using the form below and we will get back to you as soon as we can. Unser Solutions Pte Ltd.
Unser Solutions Pte Ltd - Service
http://www.unser.biz/service2.html
Good Distribution Practice for Medical Devices (GDPMDS) is a quality management system (QMS) specific for distributors of medical devices. GDPMDS ensures that your products are consistently stored, transported and handled under suitable condition as required by the marketing authorisation or product specification. It will also ensure that your company has appropriate system to comply with post-market requirements, including adverse event reporting and field safety corrective actions (FSCA).
Unser Solutions Pte Ltd - Our People
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Seet Wing Gang has more than 10 years of quality and regulatory affairs experience in medical devices. He has strong experience in product registration in Asia Pacific countries. He has also experience in creation and maintenance of technical file and design dossier for CE marking as well as US 510(K) filing. Seet Wing Gang holds a Master of Technological Design, a joint master offered by National University of Singapore (NUS) and the Eindhoven University of Technology (TU/e), and a B. Sc Degree in C...
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In unseren Herzen seit ihr bei uns. Cedric *16.12.1977- 10.09.2004. Annett *03.04.1975- 04.03.2005. Heidi *17.09.1957- 17.02.2006. Christiane *26.02.1960- 03.08.2004. Ewald *10.02.1958- 19.03.2006. Angel 04.12.1976- 02.04.2006. Andreas 16.04.1957 - 25.11.2005. Günter 26.05.1950 - 12.05.2007. Achim 27.09.1949 - 26.08.2008. Hans-Günter 01.12.1930 - 19.11.2008. Francisco, 03.02.1951 - 19.01.2009. Omi, 28.01.1919 - 10.10.2009. Domi, 03.07.47 - 27.12.05. Wolfgang 31.01.1953 - 04.11.2012. Und du bist da. Und b...
Unser Solutions Pte Ltd
We work with companies to meet regulatory requirements for medical devices. Unser Solutions Pte Ltd.
Unser.ca
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