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

Mitigating Risk Through Quality Assurance Policies


In today's ever-evolving regulatory world, it is critical for medical instrument companies to develop guidelines that will comply with continually-changing regulatory requirements.  How can companies and employees stay abreast of all the complexities and moving parts to achieve compliance? Having a protocol in place is essential. Here are five QA components to take into consideration when creating policies and procedures. 

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Topics: medical device quality assurance, medical manufacturing quality management

3 Key Non-Compliance Warning Signs in Medical Device Design

In a recent article that appeared on Med Device Online, Susan Gould, of the Halloran Consulting Group weighed in on potential regulatory compliance pitfalls and how to spot the warning signs before your company is looking at multiple 483s.

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Topics: medical device quality assurance, medical manufacturing quality management

Quality Assurance Best Practices in Contract Manufacturing

Several factors play into a successful contract manufacturing program. Some of these factors result in reduced expenditures, increased time saving capabilities, and error free development practices. For 35 years, KMC Systems has been continuously refining our manufacturing processes to successfully and seamlessly bring compliant medical devices to market. KMC Systems produces groundbreaking medical instrumentation by leveraging our years of experience and employing three key priorities for quality assurance during the design, development and manufacturing phases.

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

Introducing Medical Devices to Market with the Help of Systems Engineering

Ensuring successful introduction to market is no small feat. Product development first starts with accurately documenting requirements prior to design, which secures the developed product will meet the intended use.  Read More

Topics: medical device design, medical device design and manufacturing, medical device quality assurance, Systems Engineering

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

Medical Quality Control: KMC's Gail Wiegand’s Passion for Excellence

This is the third in a three-part series on KMC Systems' medical device quality assurance practices.

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Topics: KMC Systems, medical device development and manufacturing, medical device quality assurance

KMC's MES and Robust Medical Device Quality Assurance System

This is the second in a three-part series on KMC Systems' medical device quality assurance practices.

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

KMC’s Medical Device Manufacturing Quality Assurance Program

This is the first in a three-part series on KMC Systems' medical device quality assurance practices.

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