Sanbor Medical Blog | FDA

A Basic Explanation of OEM Contract Manufacturing

2 minute read

Contract manufacturing is a specialized form of outsourcing. One business contracts with another business, which manufactures a specialized component or product formulation for consumers, such as in the food or pharmaceutical industries. A large scale example of contract manufacturing occurs in the...

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medical devices, medical outsourcing, FDA, compliance, regulatory, medical device contract manufacturing
7 minute read
| February 13, 2024

FDA Compliance and Audits in Medical Device Contract Manufacturing

In the dynamic and highly regulated landscape of medical device manufacturing, adherence to quality standards and regulatory... Read More
FDA, medical manufacturing
7 minute read
| November 9, 2022

Advantages of an FDA-Regulated Medical Device Manufacturer

Working With an FDA-Regulated Medical Device Manufacturer For OEM medical device product makers, having an FDA-regulated... Read More
medical devices, contract manufacturer, electromechanical, OEM, medical outsourcing, finished medical device, Class I Medical Devices, Class II Medical Devices, global logistics, usa headquarters, usa based, vertically integrated, medical, healthcare, medical equipment, offshore outsourcing, electronic manufacturing services, supply chain consolidation, transfer product, medical device turnkey, new product introduction, new product development, pre-market approval, FDA, DHR, quotation process, offshore manufacturing, trends, Sanbor Medical, Contract Manufacturing, innovation
5 minute read
| April 4, 2019

5 Highly Innovative Companies of 2018

Failure to innovate is not an option for any business that wants to survive. It's important to incorporate new technology... Read More
medical devices, usa headquarters, usa based, vertically integrated, medical equipment, electronic manufacturing services, transfer product, new product development, pre-market approval, FDA, DHR, medical manufacturing, Class I Medical Device, Class II Medical Device
2 minute read
| March 26, 2019

Electromechanical Products: From Prototype to Full Scale Production

You've been checking off those boxes one by one. Research & Development: Check. No one has made this product before, and... Read More
medical devices, outsource, contract manufacturer, electromechanical, OEM, medical outsourcing, offshore manufacturer, finished medical device, Class I Medical Devices, Class II Medical Devices, global logistics, usa headquarters, usa based, vertically integrated, medical, healthcare, medical equipment, overseas outsourcing, offshore outsourcing, electronic manufacturing services, supply chain consolidation, transfer product, medical device turnkey, new product introduction, new product development, FDA
4 minute read
| May 8, 2018

How to Choose from Different Medical Device Contract Manufacturers?

Sanbor Medical, as a highly experienced (28 years in operation, 17 years in medical) CM (contract manufacturer), receives a... Read More
medical devices, outsource, contract manufacturer, electromechanical, OEM, medical outsourcing, offshore manufacturer, finished medical device, Class I Medical Devices, Class II Medical Devices, global logistics, usa headquarters, usa based, vertically integrated, medical, healthcare, medical equipment, overseas outsourcing, offshore outsourcing, electronic manufacturing services, ems, supply chain consolidation, transfer product, medical device turnkey, new product introduction, new product development, DHF, pre-market approval, DMR, FDA, Class III Medical Device, 510k, DHR, compliance, PMA, regulatory
5 minute read
| April 24, 2018

The Importance of DHF, DMR, and DHR

We’ve mentioned the three Ds of medical device manufacturing previously on this blog; they play a significant role in... Read More
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