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.
Gerresheimer, a manufacturer for the pharma and life science industry, will invest more than $88 million in expanding its manufacturing operations in Peachtree City, creating over 200 new jobs for Fayette County.
MasterControl Inc. is the #1 Quality Management System (QMS) for Life Sciences. As a top provider of cloud-based quality and compliance software for life sciences and other regulated industries, our mission is the same as that of our customers – to bring life-changing products to more people sooner.
Automated SPC software can help organizations take their quality approaches from reactive to proactive, boosting efficiency and getting everyone on the same page. Read on to learn how companies in transportation and defense, consumer goods and construction materials, food and beverage, and medical devices and pharmaceuticals companies can meet quality requirements, industry regulations and more.
The medical field is front and center right now. Whether it’s manufacturing new ventilators or analyzing virus particles, the importance of the medical industry has never been clearer.
Medical device implants have become increasingly more complex over time as technology has progressed into providing a new way of construction by the means of 3D printing, also known as additive manufacturing.
Medical devices require stringent quality and inspection methods.
March 1, 2020
The medical industry stands out from other aspects of manufacturing. The inspection rates are often higher, quality is paramount, and the products could be implanted into the human body.