Accumold announced that it has achieved successful ISO 13485 recertifiction, a globally recognized quality management standard for the medical device industry.
MSI Viking specializes in metrology solutions, focusing on precision measurement, quality control, and industrial efficiency. With over 50 years of experience, we provide advanced products, expert calibration, and reliable repair services to help industries achieve top accuracy and performance.
Medical Manufacturing Technologies (MMT), a portfolio company of Arcline Investment Management and a leading global provider of automated, process-driven medical device manufacturing solutions, announced the acquisition of Comco, a recognized leader in the micro-precision sandblasting sector.
Quality is honored to name Attrayee Chakraborty as our 2025 Quality Rookie of the Year. Discover how she earned the award through her groundbreaking work in medical device quality and AI integration.
Kalpita Mehta is a combination products and medical device expert at a top U.S. generic manufacturer. She specializes in developing complex pharmaceutical products like COVID-19 testing kits.
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.
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.
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.
As the industry continues to trend toward a more patient-centric approach, we see an increasing buzz around the development and utilization of wearable injectors, also known as on-body delivery systems (OBDS)—the next evolution in needle-based drug delivery products.