Medical device design validation is an essential part of the product development process. Effective and efficient design validation can help ensure the smooth running of your project. It is also essential for patient and user safety, and it is a key requirement to get regulatory approval for your new medical device product. There is sometimes … Medical Device Design Validation Explained
Arrotek’s Co-Founder, Mark Pugh, has been appointed as CEO of Theragenics Corporation, the US-based parent company of Arrotek. The Theragenics Corporation includes the brands Theragenics, Arrotek, Galt, and NeedleTech. It specialises in the supply, design, and manufacture of minimally invasive medical devices. Mr Pugh succeeds Frank Tarallo who retired at the end of 2023 following … Arrotek Co-Founder Mark Pugh Named CEO of Theragenics Corporation
Braiding is an essential component in many minimally invasive medical devices, including some of the most advanced interventional and diagnostic catheters. Medical device braiding is also used in positioning devices, occlusion devices, expandable delivery sheaths, and more. As it’s an essential component, designing medical device braiding is an important part of the new product development … Designing Medical Device Braiding – Achieving Optimum Levels of Performance
The Arrotek Medical team are looking forward to exhibiting at the upcoming MD&M west show in Anaheim Convention Center, Anaheim, CA, USA from 6 – 8 February 2024. Drop by booth #2711 to meet with one of our technical sales team to discuss your next medical device design and manufacturing project.
To enhance the level of service we offer our clients, we have opened two new cleanrooms in our US facility – a Class 7 cleanroom and a Class 6 cleanroom. Find out more on the arrotek.com website – click here.
We have opened new cleanrooms in our medical device design and manufacturing facility in the US. Our base in North Attleboro, Massachusetts now has two new cleanroom facilities, extending and enhancing the service we offer to customers. The new cleanrooms in our US facility include: Bill Fralick, Director of Quality Assurance and Regulatory Affairs at … Arrotek Opens New Cleanrooms in US Facility
Transcatheter aortic valve implantation (TAVI) systems are commonly used in procedures to treat aortic stenosis by improving the flow of blood in the heart. This can have a transformative impact on patients, especially as TAVI procedures are minimally invasive and significantly reduce the need for open heart surgery. TAVI procedures are also referred to as … Designing Transcatheter Aortic Valve Implantation (TAVI) Systems
Design for manufacturing (DFM) or design for manufacturability involves designing a medical device component or product so it can be efficiently manufactured. Adopting DFM principles during the product design stages of your project ensures a smoother design transfer process and, ultimately, improves the quality of your product once manufacturing begins. Examples of the questions that … Medical Device Design for Manufacturing (DFM) Best Practices
Design for Manufacturing (DFM) is a set of principles that ensure new medical device products can be efficiently manufactured. The primary goal of DFM is to reduce manufacturing complexities, costs, and problems while maintaining quality, safety, and performance, particularly in relation to the product’s defined functionality requirements. The elements of a product’s design that engineers … Design for Manufacturing (DFM) Best Practices When Designing Medical Device Products
Sensors are becoming increasingly critical components of new and innovative catheter products. As sensor technologies develop further, a number of design considerations must be taken into account when integrating sensors into catheters. A key objective in the design process is to ensure the catheter is safe and performs as intended. When that is achieved, sensors … Design Considerations When Integrating Sensors into Catheters
