Three Quality Subsystem Improvements That Streamline FDA Compliance
IntroductionMaintaining readiness for FDA inspections can be arduous and time-consuming, and the need for preparedness is growing. While the FDA continues to issue more observations than Form 483s, the number of observations has been decreasing, while the count of Form 483s has been increasing. A renewed focus on the quality subsystems that are most frequently cited with issues in Form 483 inspections can streamline FDA compliance and inspection readiness. Here ...
Dec. 10, 2018
Eliminate Barriers to Innovation Part IV
Connecting Products and Projects Helps Streamline Regulatory Compliance This is the fourth and final part of our series on how to break down the barriers to product innovation. We have demonstrated how to connect disparate product teams with a single source of truth to simplify collaboration, streamline new development, and keep up with engineering changes. Now we will discuss tips on how to create and maintain a proactive project management ...
Dec. 5, 2018
Eliminate Barriers to Innovation Part III
Meeting Product Requirements and Streamlining Engineering Changes Throughout this series, we have been exploring how manufacturers can streamline new product development and new product introduction (NPDI) by connecting the entire new product team with a centralized product record for a single source of truth. During the first installment, we covered the challenges product companies face in delivering a new product to market. And in part two we shared tips on ...
Nov. 27, 2018
Eliminate Barriers to Innovation – Part II
Bringing Teams and Products Together In the first part of this series, we discussed the three largest challenges companies face in developing and manufacturing products through new product development and introduction (NPDI) processes: A complex environment of global regulationsGlobally distributed NPD and NPI teamsCross-functional IoT design in a world of connected smart devices. All three place a major burden on your product development teams throughout the entire NPDI process. To ...
Nov. 15, 2018
3 Key Challenges Facing Medical Device Quality Leaders
Medical Device Quality PressuresQuality leaders face a lot of pressure in their role in delivering safe, high-quality products to market. In the medical device industry, that weight is even greater as the quality of their products can have a direct and dramatic impact on a person’s health. Successfully navigating a sea of FDA, ISO, and other regulatory requirements is a primary source of this pressure to deliver medical devices ...
Nov. 8, 2018
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