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  Knowing the Limits for Successful Medtech Design Transfer

  In the fast-paced world of medical device development, ensuring a smooth design transfer is critical for product success. However, a common pitfall arises when limits around essential performance are not well defined. In his recent article for Medical Product Outsourcing (MPO), Dana Trousil, StarFish Medical’s Mechanical Engineering Team Manager, dives into the challenges and solutions for addressing these issues.

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  Validating Filter Integrity for Biopharmaceutical Manufacturing

  Filter Integrity Biopharmaceutical Manufacturing explores the relationship between microbial retention tests and integrity tests essential for validating the effectiveness of filters in critical applications.

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  Visual Project Management Improves Manufacturing Performance

  Ensuring on-time medical device manufacturing builds are done in a timely manner requires coordinating across several teams including engineering, manufacturing, and quality. Visual Project Management (VPM) and Manufacturing Production Schedules (MPS) help improve manufacturing performance and meet build delivery deadlines.

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  33 Solid Medical Device Manufacturing Tips

  33 tips and examples from commercialization experts for manufacturing a medical device.

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  Pro Tips for Medical Device Transfer to Manufacturing

  Medical Device Transfer to Manufacturing tips and examples from building a solid foundation to logistics.

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  Important Considerations when Designing Labels for Medical Devices

  Considerations for designing UDI labels for medical devices include ANSI/ISO Parameter Values, label verification and durability.

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  Four Ways to Add Value Post Medical Device Transfer

  Questions to evaluate your capability post medical device transfer and reinvest in your product to add value.

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  Writing Effective SOPs for Manufacturing Medical Devices

  Writing and implementing standard operating procedures (SOPs) for the manufacture of medical devices is required by ISO 13485, FDA, and other regulatory bodies. An SOP is a set of written instructions that documents a routine or repetitive activity that is followed by employees in an organization. The development and use of SOPs are integral parts of a successful quality system. They provide directions to perform a job properly and consistently to achieve predetermined specifications and quality end results. SOPs address all requirements to complete the job or process safely and effectively.

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  What do Mil-Spec Anodizing Types and Classes Mean?

  Features and benefits of different Mil-Spec Anodizing Types and Classes of anodized coatings in North America.

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