ARTICLES

Technical articles focused on the design, development, and commercialization of single-use regulated devices. 

Recent Articles

7 Steps to Effectively Dual Source a Supply Chain for Medical Devices

In Brief

Dual sourcing is considered a hassle by some traditional medical device manufacturers. After all, the procurement process is faster and more straightforward when you only have to issue purchase orders and receive components from one vendor. Adding a second supplier to your list of approved vendors takes time and creates additional work for your accounts payable staff. 

 

In reality, dual sourcing can be accomplished efficiently and can be a win-win solution if you follow a few key measures. Below is a look at some of the benefits of dual sourcing and your seven-step guide to effectively dual sourcing a supply chain for medical devices. 

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White Paper: MedTech Supply Chain Strategies

Abstract

In today's evolving regulatory environment, supply chain transparency is a game-changing differentiator. Collaborating with manufacturing partners who have excellent supplier relationships and a deep understanding of materials can revolutionize the product development process. Even after a robust supply chain has been established, there are still hurdles in commercializing a medical device.

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5 Essential Activities of Current Good Manufacturing Practices

In Brief

Medical Device manufacturing has to comply with FDA guidelines and regulations for tracking each and every step of the manufacturing process, including raw material sourcing. These guidelines are known as current good manufacturing practices (cGMP) and each facility that is FDA certified is also regularly inspected. The cGMP regulations are published in the Federal Register in 21 CFR Part 820 for Medical Devices.

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