Stay ahead of the curve with information on the latest medical manufacturing markets where innovative technologies and processes are used to produce life-saving and life-changing medical devices that meet the highest standards of quality and safety.
Contract manufacturers can enhance their competitive advantage by applying quality best practices from the medical and aerospace industries, both of which demand flawless performance and strict contamination control.
This article will explore how mass finishing technologies, shot blasting, and bespoke solutions for additive manufacturing (AM) parts play a pivotal role in the final stages of medical device production.
Integration of digital twin technology in medical device manufacturing provides the potential to improve device performance, optimize production processes and reduce quality defects.
This article will explore digital twin technology, its effects on medical device manufacturing, and the associated benefits and challenges. The global market for digital twins was valued at over $8.6 billion in 2022 and is projected to reach $138 billion by 2030.
Calibration is essential for maintaining quality and safety in industries like pharmaceuticals, food and beverage, and chemicals. The future looks to digital certificates and AI technology to make calibration processes faster and more efficient. This article discusses how AI is set to transform calibration.
I have worked in regulatory and quality teams for surgical eye implants, virtual reality based devices and wearables for remote patient monitoring, along with providing thought leadership on artificial intelligence regulation.
How did I end up working with medical devices? Reflecting on my career, it's been diverse. Three years ago, I was working on protein structure in research labs. I never thought I'd be in the world of quality later on!
By establishing precise parameters for success from the outset and implementing proven strategies, manufacturers can proactively mitigate risks, streamline operations, and foster a culture of excellence.
Ensuring high quality in medical device manufacturing requires operational excellence, which optimizes efficiency and enhances product quality and compliance. Let’s explore some of the key elements and best practices.
In the medical device industry, reliability is critical. Manufacturers conduct extensive testing to ensure devices meet required standards, such as 95/95 or 95/99 confidence and reliability, assessed using Minitab Statistical Software.
In a world where AI vision technology is setting new quality control standards across industries, machines can now detect even the smallest defects in car parts and ensure that every packaged product meets health standards.
Here are a handful of example quality control processes that focus on the measurement of torque, with emphasis on sectors where testing is highly regulated, FDA 21CFR Part 11 being a prime consideration.
The official document is titled ISO/IEC 17025: 2017, General requirements for the competence of testing and calibration laboratories. It is the international reference for laboratories performing calibration and testing activities.