How Does Your Med Device Stack Up? | Medical Design
2024年8月8日 · Choose one with expertise in the bottoms-up co-design of devices and their production processes, with a wide range of parts, materials, and tools on hand to try and test in the early stages. Together, you can make critical, prudent decisions that will affect the bottom line of your devices and your business.
Why Perform Tolerance Stackups in Medical Device Assemblies?
2014年3月17日 · Three different methods are employed for analyzing and presenting tolerance stackups in multicomponent medical device assemblies: worst case analysis, root sum square (RSS) analysis, and statistical tolerance allocation. Each method results in progressively less variation, increasing the likelihood that a device will assemble properly.
Tolerance stack-up is a defining design concept to ensure new products are built eficiently and efectively. time when the future of micro miniature medical devices seems unlimited, one fundamental reality remains irmly in place — the sizes and shapes of human anatomy.
Tolerance stack-up: Go inside high-density microelectronic medical devices
2022年6月16日 · Tolerance stack-up is a defining concept for designing new products to ensure they’re built efficiently and effectively during production, and it’s much more than a theoretical construct.
A Look at a Common Medical Device Design Challenge, Tolerance Stack …
2020年3月3日 · In medical device design a common scenario to assess is the fit between tubing and some kind of connector. In the example shown here, there is an extruded PVC tubing that is inserted into an injection molded polycarbonate connector. It is required that there be a gap present between the OD of the tubing and the ID of the connector to make room ...
Medical Device Package Testing: Developing a ... - Medical Design …
The wide-ranging rules in the MDR provide guidance on how to design, manufacture, and package medical devices that minimize the risk posed by contaminants, pathogens, and residues to patients. In addition, the medical device must remain sterile and not adversely affected during transport and storage conditions, and the integrity of the ...
Medical Device Design and Development: A Definitive Guide
2017年10月23日 · Design and development of a medical device is the most crucial phase for its success. A loosely-defined and designed medical device cannot comply with the regulatory needs and make it to market.
Six Key Design Features to Ensure Medical Device Packaging …
2020年6月4日 · Whether a new or seasoned packaging designer for medical devices, this article will help to meet ASTM D4169, resulting in fewer failures in shipping and ensuring successful and safe delivery of a medical device.
Design V&V: What You Should Know - LinkedIn
2023年10月1日 · Bringing a medical device to market demands an unerring dedication to safety, quality, and efficacy. A pivotal juncture in the development process is the Design Verification and Validation...
How to execute a seamless medical device design transfer …
Transferring design to production is a process that can be fraught with risk for medical device developers. How can you be sure no one in your supply chain drops the ball as they assume control of the product you’ve taken so long to design and develop? What do the FDA and ISO 13485: 2016 say about design transfer?