Regulatory Articles

  1. Laser Cut Nitinol Tubing Fatigue Coupon: FEA’s Role In Design, Testing, And Endurance Limit Determination
    3/11/2019

    Nitinol medical device implants made from laser cut tubing often require a fatigue assessment, which makes determining the material fatigue properties necessary. Towards the goal of determining the strain-based endurance limit of medical grade super-elastic Nitinol tubing, a coupon was designed and evaluated via FEA using Abaqus software, produced via laser cutting, shape setting, and electro-polishing processes, and then fatigue tested to 10 million cycles. This white paper discusses the FEA’s role in design, testing, and endurance limit determination within the Nitinol tubing coupon.

  2. Evaluate Medical Device Design Robustness By Combining Statistical And Probabilistic Tools With Finite Element Analysis
    1/25/2019

    FEA has been used to analyze the in vivo structural response of implantable medical devices and assess device performance, reliability and durability. In this study, FEA using Abaqus is used to demonstrate how these techniques work together to evaluate the robustness of medical device designs.

  3. Streamline Medical Device Compliance With Jama: How Jama Simplifies FDA Compliance By Improving Processes
    2/8/2018

    Instead of focusing on FDA-regulation as the driving force in product development, compliance should instead be an outcome of a streamlined process that ensures a safe and reliable product is delivered to market. Achieving compliance, and creating the documentation, is an outcome of the focus and rigor required for regulated product development. This article discusses how Jama Software can simplify FDA processes by improving development and production.

  4. How To Avoid Compliance & Timeline Risks When Selecting A Medical Device Supplier
    12/13/2017

    Discover the 9 elements of a predictable quality system when evaluating CMO partners. Predictable quality shortens your time to market, reduces your compliance risk, and reduces risk to the patient.

  5. How To Recognize Effective CAPAs And A Culture Of Quality
    10/13/2017

    When OEMs choose an outsourcing partner, they need to trust the effectiveness of the supplier’s CAPA program, and they need to trust that the supplier’s culture sustains quality each and every day, for every device.

  6. OEMs: Do You Trust Your Medical Device Supplier’s Quality?
    8/1/2017

    As an OEM, it is your responsibility to ensure the parts supplied to you are compliant with ISO regulations. Ideally, your supplier’s quality systems are strong enough to identify risks, prevent defects, and to catch defects quickly if they do occur. This requires a robust quality management system. 

  7. Managing The Unpredictability Of The Product Development Process
    8/1/2017

    How development teams need to engage in the holistic, programmatic risk management necessary for a predictable development program.

  8. Incorporating Stress Into User Testing
    8/1/2017

    How do you design a usability test that mimics the panicked, stressful situation that a user may be in when he or she is using your medical device in the real world?

  9. Are You Gambling With Medical Device Compliance?
    1/5/2017

    OEMs can ease their burden of ensuring CMO regulatory compliance by selecting a CMO with a fully integrated system for DHR creation. Not only can such a system eliminate the inaccuracies of paper records, but it enforces documentation and automates error prevention.

  10. Is Your Medical Silicone Molding Company FDA Ready?
    8/17/2016

    The U.S. FDA and the European Commission (EC) have increased their surveillance on medical device manufacturers and their suppliers. This article discusses how to evaluate audit readiness for a medical silicone molding company, as well as preparing to move toward global quality standards.