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.
Finite Element Analysis (FEA) has been widely used to analyze the in vivo structural response of implantable medical devices and assess device performance, reliability and durability. In order to obtain a robust design, parameter variations and their influence on device performance need to be understood. Probabilistic analysis techniques like Monte Carlo sampling combined with FEA clarify these stochastic processes and in determining probability of failure and design reliability. In this study, FEA using Abaqus is combined with statistical and probabilistic analysis using Isight to demonstrate how these techniques work together to evaluate the robustness of medical device designs.
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.
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.
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.
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.
How development teams need to engage in the holistic, programmatic risk management necessary for a predictable development program.
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?
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.
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.
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