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

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

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

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

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

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