Validation and Contract Manufacturing – The Make or Break Relationship

Bob Marshall, chief editor of Med Device Online, recently published the fourth article in a series of five about medical device development and FDA approvals. In this article, he addresses the importance of validation and manufacturing transfer in the scheme of preparing for FDA inspections. “You have proven your concept, fully specified your design, and verified that the design output satisfies your design input requirements,” he states, “It is time for the most pivotal portion of the product development life-cycle. I like to call this fourth stage; validation/manufacturing transfer.” He calls this phase the dress rehearsal for commercialization.

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Topics: medical contract manufacturing

Plan for Success with Sustaining Engineering in Medical Device Development, Manufacturing

When your medical device development project is under pressure to get to market and the project is critical to your company’s success, you'll need a dedicated outsourcing partner who can provide engineering expertise that includes sustaining engineering. How can sustaining engineering ensure successful handoff to manufacturing?  KMC's  executive director of engineering, Scott Leon, weighs in.  

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Topics: software engineering, medical sustaining engineering

Let's Meet at AACC 2017 July 30 - Aug. 03 in San Diego

We hope to see you in San Diego for AACC 2017! Every year we look forward to connecting with global leaders in clinical chemistry, molecular diagnostics, mass spectrometry, translational medicine
 and other areas of groundbreaking discoveries in medical and life science innovation. KMC Systems will be at booth 5423. Please stop by!

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Topics: AACC

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

What's so Cool About Manufacturing? Londonderry Middle School Students Win NH Economic Business Development Video Contest.

KMC Systems was proud to participate in Londonderry Middle School's project and submission to the New Hampshire Division of Economic Development's What's So Cool About Manufacturing? Contest. 2017 marks the the third year that New Hampshire middle school students have competed in a "What's So Cool About Manufacturing" contest to investigate, interpret and report on manufacturing in NH. 

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Topics: medical manufacturing

KMC Celebrates National Engineers Week!


February is an exciting month at KMC Systems because we get to celebrate National Engineer's Week with our hard-working teams! This year, Engineer's Week takes place on Feb. 19-25 and KMC Systems is celebrating the many contributions that engineers make to society through ingenious invention, applied sciences and discovering emerging technologies. As a way to express gratitude to all KMC engineers and their innovative contributions that advance medical and life science instrumentation as well as raise the level of patient care, we held an ice cream social at KMC Systems. 

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Topics: Engineers Week, Engineering

Accessibility, Advantages and Challenges of 3D Printing for Designers and Developers

In an article that addresses the accessibility of 3D printing to today’s businesses as well as hobbyists and designers, Nermin Hajdarbegovic, technical editor for toptal, helps to clarify the difference technologies as well as the benefits and challenges of taking on 3D printing. Hajdarbegovic states, “3D printing is not a new technology, but recent advances in several fields have made it more accessible to hobbyists and businesses.” He also poses some important questions.

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Topics: medical manufacturing, 3D Printing

Join KMC at Molecular Med TriCon 2017 in San Francisco

In just a few short days, over 3,500 life sciences professionals will be gathering at Molecular Med Tri-Con 2017 in San Francisco, February 19-24. Discover the latest developments in molecular medicine, genomics, diagnostics and information technology. KMC Systems will be at booth 123. Here's what you can expect to see at this year's #TRICON

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Topics: Trade Shows, Molecular Med Tri-Conference

Explore Life Sciences with KMC at SLAS2017!

What to expect at SLAS 2017

The KMC Systems team is headed to Wasthington DC for SLAS 2017, February 4-8! Industry leaders in life sciences, diagnostics and emerging technologies will meet at the Walter E. Washington Convention Center for SLAS 2017. Be sure to visit KMC at booth #1601! Here's what to expect at this year's SLAS conference. 

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Topics: SLAS

Important Changes to ISO 13485 2016 for Medical Device Manufacturers, Designers

In 2016 new ISO 13485:2016 Medical devices — Quality management systems — Requirements for regulatory purposes were published. This set into play a new international framework for requirements in an effort to mitigate risk in the production of compliant, reliable medical devices. Companies are granted a 3-year transition period. Are you ready? 

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Topics: quality assurance, regulatory control, ISO 13485