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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FDA, medical device compliance, medical device quality, ISO 13485
13 minute read
| January 22, 2026

Managing Change Control to Reduce Medical Device Non-Conformities

Most non-conformities in medical device manufacturing are not caused by design flaws, but by uncontrolled changes. Even in... Read More
FDA, medical device compliance, medical device quality
6 minute read
| January 8, 2026

Medical Device Quality Requirements: Compliance is the Baseline, Quality is the Lifeblood

In the medical device industry, quality can no longer be looked upon as a differentiator. It is a non-negotiable... Read More
medical devices, electronic manufacturing services, FDA, Sanbor Medical, medical manufacturing, medical device contract manufacturing, medical device contract manufacturer, medical device manufacturing, medical device compliance
6 minute read
| September 12, 2025

Portable CPAP Devices: Redefining Sleep Apnea Care

For millions of people worldwide, obstructive sleep apnea (OSA) disrupts sleep and overall health. Continuous positive... Read More
medical devices, electronic manufacturing services, FDA, Sanbor Medical, medical manufacturing, medical device contract manufacturing, medical device contract manufacturer, medical device manufacturing, medical device compliance
6 minute read
| September 3, 2025

Why FDA QSR Compliance Matters: What it Means for Your Medical Device Manufacturing Partner

Product quality for medical device manufacturing is a non-negotiable requirement. At the core of US regulations is the FDA’s... Read More
medical outsourcing, DMR, FDA, compliance, medical manufacturing, medical device contract manufacturer, medical device manufacturing
6 minute read
| January 20, 2025

FDA-Regulated Medical Device Compliance and OEM Contract Manufacturing

It’s common knowledge that medical devices sold in the US are subject to numerous regulations, most of which are imposed by... Read More
FDA, compliance, Sanbor Medical, medical manufacturing, medical device contract manufacturing, medical device manufacturing
6 minute read
| September 9, 2024

Understanding FDA Regulations for Electronic Medical Devices

FDA regulations for electronic medical devices are a complex web of ever-changing rules and restrictions that can confuse... Read More
medical devices, contract manufacturer, medical outsourcing, FDA, Sanbor Medical, medical manufacturing, medical device contract manufacturer, medical device manufacturing, supply chain resilience, supply chain agility
6 minute read
| June 12, 2024

Supply Chain Resilience in Medical Device Manufacturing | Sanbor Medical

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medical devices, contract manufacturer, medical outsourcing, FDA, compliance, Sanbor Medical, medical manufacturing, medical device contract manufacturer, medical device manufacturing
6 minute read
| May 7, 2024

Why a Quality Management System is Essential for Medical Device Manufacturers

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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
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