MDR Solutions
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Learn More About Us
MDR Solutions
Medical Devices and Robotics Regulations
Our CEO
Dr. U-Thainual is a CEO at MDR Solutions, which she founded. She received B.Eng in Mechanical Engineering and M.Eng degrees in Biomedical Engineering from Mahidol University, Nakorn Pathom, Thailand, in 2005 and 2007 respectively. She received her Doctoral degree in Mechanical Engineering (Major in Medical Robotics) from Queen’s University, Ontario, Canada, in 2013. She joined U.S. Food and Drug Administration, Center for Devices and Radiological Health, Silver Spring, MD, USA, as a research scientist in 2013. In 2016, she joined Thailand Center of Excellence for Life Sciences (TCELS) as a senior project manager in the Division of Medical Device and Medical Robotics.
She has strong background in design and develop medical devices and medical robotics. She designed and prototyped novel devices, and ushered those technologies through safety and feasibility studies, hand in hand with a cadre of leading clinical innovators.
About MDR Solutions
MDR Solutions provides a wide range of services with leading experts in the US FDA medical device and medical robotics industry.
Since 2017, we have already been providing customized solutions to various overseas medical device companies and are gradually expanding our expertise.Close partnership with industry help to infuse a practical perspective, allow us to provide tremendous services to our customers.
It is our attitude and determination to deliver the best solutions to our customers
Our Partners
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BT Solutions, Inc. (South Korea)
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BT Solutions, LLC. (United State of America)
Our Visions
To become a global consulting firm that provide the best solutions and help medical device businesses to comply with Food and Drug Administration (FDA) domestically and internationally.
What We Do
01
Registration, 510(k), PMA advisory and agency
02
Thai FDA Registration, CSDT and Listing, advisory and agency
03
Planning and execution of clinical trials
04
Pre-Consultations on the Standards required for Medical Devices and Medical Robotics
05
Lecture and Seminar
Registration
Thai FDA:
Thailand domestic and foreign medical device manufacturers looking for register medical product in Thailand need to be allowed to manufacture, import, sell and advertise by Medical Device Control Division of Thai Food and Drug Administration (TFDA). Nowadays, in Thailand, medical product was categorized into 3 groups:
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Notified Medical Devices
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Physical therapy devices
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Alcohol detector devices
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Silicone Breast Implants
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Breast enhancer
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Methamphetamine test kit
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Ophthalmic Viscosurgical device (OVD)*
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Licensed Medical Devices
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Condoms
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Examination and Surgical gloves
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Contact Lenses
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HIV test kit*
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Blood bag*
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General Medical Devices
Medical product which was not mentioned above is General Medical Devices.
Notation: * represent the medical device required sale license
Contact us to consult our expert for free
US FDA:
We provice services on
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Registration
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510(k)
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PMA
Contact us to consult our expert for free
MDR Solutions" is serving our clients internationally and domestically with expertise and experience that set us apart as a leading provider of FDA compliance assistance since 2017. Our highly skilled consultant team continuously work toward enhancing the efficiency of the FDA approval process for our clients and providing high-quality services tailored to client's need. We are committed to provide the optimal solutions by keeping our clients informed on the constantly changing FDA regulatory landscape
Pre-consultation
we provide pre-consultation service on
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Standards requirement
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Clinical studies protocol
Moreover, we provide services about clinical studies/observational studies design and execution
Contact Us
MDR Solutions Co.,Ltd.
1435 Kanchanaphisek Rd.,
Bang Khae Nue, Bang Khae,
Bangkok 10160, Thailand
Open Monday to Friday 9pm to 4pm
Tel: +66-2-804-2101
Fax: +66-2-804-2100
Email: info@mdrsolutions.co.th
Get In Touch