Little Known Methods for FDA Medical Device Approval

We are all well aware of the many processes and regulations that must be adhered to in order to achieve FDA medical device approval. Now the FDA says there are certain methods that may allow for the approval of more medical devices. What specific criteria does the FDA look for? What does it take to ensure that medical devices are safe and effective? A recent article explains. 

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Topics: medical device manufacturing, quality assurance

Expansive Growth Predictions; Medical Device Manufacturing 2017



The medical device market is growing at a rapid rate. With advancements in technology and manufacturing capabilities, medical instrument companies are seeking accelerated time to market and improved quality and cost control. How do these changes influence market sales and the selection of an outsourcing partner?  

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Topics: medical device manufacturing, 3D Printing

4 Types of FDA Inspections and What They Mean to Medical Manufacturers

There are many different criteria which medical manufacturing companies and medical instrument companies are required to meet for FDA approval. One of these areas is the inspection of medical device manufacturers.  If you are in the medical instrumentation industry, how do you successfully and seamlessly bring compliant medical devices to market? 

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Topics: KMC Systems, Medical Product Manufacturing, medical device manufacturing, medical device design and manufacturing, medical device quality assurance

6 Manufacturing Mantras - Which Do You Live By?

Medical device companies face many challenges in today's market, with the global economy, outsourcing, and product safety concerns. Maintaining and performing at a high level of standards produces safe, high-quality products with a reasonable return on investment. But how can you increase productivity while maintaining robust quality standards? These 6 manufacturing mantras can help you stay on track without skipping the essential checkpoints. 

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Topics: medical device manufacturing

Manufacturing Readiness Assessment Tool -Are You Ready for Production?

Whether partnering with a medical contract manufacturer or manufacturing in-house, transitioning from product development and design to the manufacturing phase of a project can have many challenges. This Manufacturing Readiness Review Checklist can be used as a transition tool to determine the readiness of a program to move into production.

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Topics: medical device manufacturing, medical contract manufacturing, design for manufacturability, medical manufacturing

Medical Innovation at KMC Systems: A Program Manager's Perspective

KMC Systems Program Manager Paul Dahlstrom shares his perspective on KMC's medical innovation through medical device design, development and manufacturing, which provides solutions that protect and save lives.

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Topics: KMC Systems, medical device design, KMC, medical device manufacturing, medical device development, medical innovation

The Role of Quality Assurance in Medical Device Manufacturing

KMC Systems Director of Quality Assurance and Regulatory Compliance Gail Wiegand discusses how the Quality Assurance team aids in the medical device manufacturing process.

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Topics: medical device manufacturing, medical device quality assurance, medical manufacturing

Why OTD Matters When Choosing a Medical Contract Manufacturer

This is the second in a three-part series on how to improve medical device on-time delivery performance.

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Topics: medical device lean manufacturing, medical device manufacturing, medical device supply chain management, medical device on-time delivery performance, OTD, medical supply chain

Lean medical device manufacturing process in KMC production cells

This video shows the main concepts and tools that we use in KMC Systems' lean medical device manufacturing environments to deliver medical instrumentation in a quicker, more cost-effective manner.

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Topics: KMC Systems, medical device lean manufacturing, lean manufacturing, medical device manufacturing, lean medical manufacturing

KMC Systems' Top Medical Device Manufacturing Posts of 2013

KMC Systems has had an eventful and successful 2013, and we hope you have, too!

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Topics: medical device contract manufacturer, medical device contract manufacturing, medical device manufacturing, medical contract manufacturing, KMC Systems; medical device; medical device blog, medical contract manufacturers, contract medical manufacturing, medical manufacturing companies