Lisa Cuipa

Recent Posts

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

Today's the Last Day for AMP 2016 Advanced Registration! Register now.

In less than 3 weeks industry leaders in molecular medicine will gather for the Association for Molecular Pathology (AMP) 2016 Annual Meeting in Charlotte, North Carolina. Today is the last day for advanced registration! If you haven't registered yet, you can do so right here: 

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Topics: Trade Shows, molecular medicine

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

Advancing Diagnostics at the Next Generation Dx Summit 2016

With more than 1,000 diagnostic industry leaders from 29 different countries, the 8th annual Next Generation DX Summit sets the stage for prime learning and networking opportunities within the diagnostics development field. Expecting another groundbreaking, record year for attendance, the expo is sure to make an impact. KMC Systems will be exhibiting at booth #18.  Join us in Washington, DC from August 23-26. We hope to see you there!

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Topics: next generation dx summit, Trade Shows

ASM2016: The KMC Systems Team Will See You There

ASM Microbe 2016 is underway! We hope to see you at this exciting event for professionals, students and industry leaders interested in microbiology and microbial sciences. We hope to see you in the exhibit hall! Visit the KMC team at booth #707.

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Topics: Trade Shows

Are you ready for manufacturing? Find out with this Manufacturing Readiness Review checklist.

How do you turn your groundbreaking idea into innovative new medical instrumentation? You may have even devoted hours developing the concept and designing a prototype, so what's next? Are you ready for manufacturing? Has your prototype gone through the proper scrutiny and testing to transition to manufacturing? How about quality control and requirements?

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Topics: medical contract manufacturers, medical device design and manufacturing

The TRI-CON App is Here! Optimize Your Time at the Event.

Are you going to Molecular Med TRI-CON, the premier event for molecular medicine & diagnostics?  The official meeting app was just announced. Download the app now to make the most of your time at the event! 

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Topics: Trade Shows, Molecular Med Tri-Conference, molecular medicine, tri-con 2016

Adios SLAS2016. See You in Washington, DC for SLAS2017!

The KMC Systems Team enjoyed a record breaking event at SLAS2016 which brought in 6,293 life sciences and R&D professionals! It is always great to meet new people, and catch up with long time industry peers. How was the annual conference and exhibition for you and your team? Please share comments about your SLAS 2016 experience and read more about ours below. 

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Topics: Trade Shows, SLAS2016

Verification and Validation; Requirements in Medical Device Design

The process of verification and validation is a critical component for the effective development and design of medical devices. Besides the ultimate need to comply with regulations, keeping the design, manufacture and user requirements in mind during development helps facilitate efficient transition from phase to phase of your medical device project. Putting in place and adhering to the proper production processes yields instruments with a higher manufacturing rate, fewer mistakes, a quicker time to market, and lower production costs. At KMC Systems, quality is not just a requirement, it's our culture. Read More

Topics: medical device design, quality assurance