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