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Resources to Help Accelerate Your Product Development

Our goal is to help you learn, implement and succeed.  See our blog, white papers, webinars, and other content from our experts.  All content is freely downloadable.

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CAPA:  A Review of 21 C.F.R. §820.100 and FDA Warning Letter Trends

CAPA: A Review of 21 C.F.R. §820.100 and FDA Warning Letter Trends

SPK and Associates routinely review warning letters to help our clients stay in step with FDA trends.   One of the problem areas most often cited in company audits continue to be the CAPA system/program.   This month we will take a look at some of the latest FDA...

Latest White Papers

Leveraging PTC Integrity for IEC 62304 Compliance

Leveraging PTC Integrity for IEC 62304 Compliance

Executive Summary Our medical device customers report that up to 70% of new product innovation is being created in the software domain. This represents an increase in both volume and complexity. In this white paper, you'll learn: The 3 different use cases explained A...