Medical Device Directory

White Papers for Medical Device Industry Suppliers

  • Reverse Engineering File FormatsBy

    Reverse engineering using scan data involves collecting scan data and using it to create computer-aided design (CAD) data. There are several outputs for reverse engineering when using scan data. This white paper explains the differences and benefits/deficiencies of those outputs.
  • How to Prepare for FDA Migration from QSR to ISO 13485 and QSIT to MDSAPBy

    The FDA has announced plans to transition to standard ISO 13485:2016 for medical devices in April 2019. In addition, the Medical Device Single Audit Program, MDSAP, has gained traction with full implementation set for 2019. Download this paper to learn more about these two changes from the...
  • Challenges with MEMS Pressure Sensor Integration in Medical DevicesBy

    Today more value is being placed on the enhancement of medical devices through miniaturization and added capabilities such as pressure sensing components. Proper integration of a MEMS pressure sensor in a medical device requires in-depth knowledge of sensor types, capabilities, validation and...
  • Total Cost of Ownership: Offshore vs Reshore - NWI Cable Manufacturing Site PaperBy

    This Site Paper identifies the most commonly over-looked cost factors purchasing professionals and key decision-makers face when deciding whether or not to utilize offshore contract manufacturing companies in their procurement strategies. This paper discusses the best strategies to compete...
  • Coil on Plug TestingBy

    ETCO Incorporated | March 7th, 2012: R&D has been working on a lab fixture that will trigger coil on plug type coils. It will use this tool to compare industry standard coil to plug connections (typically a spring) with each other, and with prototype ideas, seeking to offer a better connection....
  • What IQ/OQ/PQ Services Are - and Why You Need ThemBy

    Equipment validation – often referred to as Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) – provides you with a way of assessing how well your equipment is functioning. IQ/OQ/PQ may also be required by association, state, or federal...
  • Three Key Strategies for Successful QMS: How to Integrate Quality into Company CultureBy

    Empowering quality functions helps organizations achieve compliance with regulations - standards like ISO 9001 and ISO 13485 emphasize company-wide commitment to quality. But beyond that, making quality a significant part of a company culture leads to the consistent production of safe, effective...
  • What's best for your project, a product development firm or a "full-service" manufacturer?By

    Sourcing and qualifying outsource partners is a daunting task for companies who require product development and manufacturing services. We are often asked which is more advantageous, to hire a company that provides both services, or outsource from separate organizations. Without thinking it...
  • Things to consider when wire and small-hole EDMBy

    Electrical discharge machines have been used commercially for more than 30 years, with the tool and die industry being the first to adopt the technology. Since then, other manufacturing sectors have steadily added EDM to their parts-producing capabilities.
  • AC or DC DriveBy

    Which is best for small motors?
  • Thermal Analysis Unlocks the Secrets of ElastomersBy

    Analysts can reverse engineer elastomers which allows companies to improve on specific formulations.
  • Basics of Force Sensors Study GuideBy

    The study guide, “Basics of Force Sensors”, explores the different technologies engineers can choose from in selecting the ideal force sensing-device for a design project. This all-encompassing guide highlights key factors to consider in the sensor selection process: price, accuracy, and ease of...
  • ABCs of RFID: Understanding and Using Radio Frequency IdentificationBy

    Radio frequency identification (RFID) is one of the fastest growing and most beneficial technologies being adopted by businesses today. Adoption of this automatic data-collection (ADC) technology has recently been fueled by the establishment of key standards, retailer and government mandates,...
  • Polarization in Piezoceramic MaterialsBy

    One can think of a piezoceramic as a rock which generates electrical current if squeezed and which moves if driven by an electrical current. For these wonderful properties to occur electrodes must be connected to the piezoceramic and the piezoceramic must be polarized. Electrodes are metal...
  • Guidelines for Selecting ValvesBy

    There is much to consider when choosing the right valves for an application. Here are some basics, important considerations, and guidelines for energy efficiency.
  • Plasma Surface Modification of PolymersBy

    Material selection of polymer components and disposables is determined by various factors such as physical/optical properties, cost, biocompatibility, etc. However, due to the hydrophobic (non-wetting) characteristics of many polymers, challenges can occur when bonding, coating or printing are...
  • Multi-Component (2K) Injection Molding / Overmolded PartsBy

    Multi-component or multi-material injection molding is a process that has developed greatly in the past decade. The process has grown not only due to technological advancements but due to OEM's searching for new ways to gain advantage over competitors in quality and value of products....
  • Tolerance Analysis: Do it Right the First TimeBy

    Discover why tolerance analysis is an integral part of the manufacturing process and learn how your firm can shorten your product life cycle and reduce waste by utilizing tolerance analysis in your next manufacturing project. Given the fact that much of the cost of bringing a product to...
  • Overview of an Ethylene Oxide Sterilization ValidationBy

    Prior to beginning routine ethylene oxide sterilization, a product with a sterile claim needs to complete a validation process to ensure the Sterility Assurance Level claimed is met. This TechTip will provide a step-by-step overview of an ethylene oxide validation process that complies with the...
  • The Environmental and Bottom Line Impact of Single-Use SystemsBy

    Explore the merits of a single-use bioprocessing system and learn how the byproduct of these systems, cogeneration, can be leveraged to save money and reduce waste. The debate of which system is better for bioprocessing, a single-use system comprised of polymer-based parts or a stainless...
  • Efficiently Compliant: Using an SPC system to comply with the FDA’s CFR Part 11 requirementsBy

    Explore the FDA’s CFR Part 11 requirements for electronic records and signatures. Discover how the right statistical process control (SPC) software program can help your organization become compliant with these rules in an efficient way. Companies that are regulated by the FDA must comply...
  • Efficiently Compliant: Using an SPC system to comply with the FDA’s CFR Part 11 requirementsBy

    Explore the FDA’s CFR Part 11 requirements for electronic records and signatures. Discover how the right statistical process control (SPC) software program can help your organization become compliant with these rules in an efficient way. Companies that are regulated by the FDA must comply...
  • ISO 8573 Compressed Air Contaminants, Purity Classes, and MethodsBy

    White paper discusses ISO 8573 sampling and analytical techniques and how Trace Analytics has developed an approach that allows determination of compliance in a straightforward and cost-effective manner.
  • Lean production and material flow in medical manufacturingBy

    12-page guidebook/brochure explores different technological approaches to lean manufacturing and assembly in a medical environment. When does it make sense to automate? When should you use a manual assembly process. Guidebook explores different application scenarios, recommends technologies for...
  • Using Infrared Light to Revolutionize the Staking ProcessBy

    Take a look inside the four basic steps of the staking process and discover how Infrastake harnesses infrared light to join plastics together in an innovative way. The process of staking plastic parts has been dominated by three main methods; hot air, thermal, and ultrasonic. Each method has...