The Benefits of Co-located Engineering and Manufacturing Teams

Need engineering and manufacturing expertise to bring your product from concept through production? It helps to chose a firm that offers both engineering and manufacturing as part of a total product lifecycle approach. Keeping your project under one roof optimizes invention and mitigates risk during the transition from engineering and design to production. Medical Device Developments spoke with KMC's Mike Kallelis about this very topic.

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Topics: medical contract manufacturing, Total Product Life Cycle, medical engineering

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

Strategies and Standards for Medical Device Signal Detection

In 2012, the Center for Devices and Radiological Health (CDRH), a branch of the U.S. Food and Drug Administration, announced four long term strategies to strengthen its National System for Medical Device Post-Market Surveillance1. Find out how these strategies correlate with medical device signal detection and why medical device firms can benefit from selecting a contracting partner with experience in Pharmacovigilance requirements.

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Topics: quality assurance, regulatory control

AMP 2016 – Connecting the Big World of Molecular Medicine

The Association for Molecular Pathology (AMP) 2016 Annual Meeting in Charlotte, North Carolina is right around the corner. KMC Systems is looking forward to this exciting event, themed "Big World. Molecular Medicine. One Community." and we hope to see you there!

With 200+ exhibiting companies, including KMC Systems at booth #203, the AMP Exhibit Hall is not to be missed! Check out these links to the most exciting features at AMP2016.

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Topics: Trade Shows, molecular medicine

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

Life Sciences and Medtech Market Predictions 2016 and Beyond

Deloitte's comprehensive look at the life sciences and biotech market in 2016 and beyond provides thorough insight into the ever-changing marketplace. Excerpts from the article entitled "2016 Global life sciences outlook - Moving forward with cautious optimism" are highlighted in this post and link to the original article. 

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Topics: In Vitro Diagnostics, medical manufacturing, supply chain management, quality assurance

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

Designing Medical Devices for Use Environments in Today's Rapidly Growing POC Marketplace

With the growing demand for delivering test results as soon as possible to the patient and physician, more complex point-of-care instrumentation is hitting the marketplace at a rapid pace. Now medical device design is more complicated due to myriad considerations that must factor in to the development and design of near-patient and in-home devices

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Topics: medical device design, medical device design and manufacturing