Ethics-GettyImages-1359117986 Quality Engineers: Are You Making The Right Call?

As a quality engineer, a lot of us have had a project leader ask us to sign off on a project when the data has too many outliers. How do you navigate that situation?

  • In the second of this two-part series, microbiology and contamination control specialists Vanessa Figueroa and Greg Gibb continue discussing best practices in contamination control strategies through the lens of the newly formalized provisions in the EU GMP Annex I. Discussion includes the elements typically found in a CCS, who in your company is responsible for developing the CCS, how often it needs to be evaluated, and more.

  • In March 2023, CDER and CBER published a Framework for the Use of Digital Health Technologies (DHTs) in Drug and Biological Product Development (the “Framework”) to “guide the use of DHT-derived data in regulatory decision making for drugs and biological products.” Here is what you need to know.

  • In the first of this two-part series, microbiology and contamination control specialists Vanessa Figueroa, Rebecca Brewer, and Greg Gibb, Ph.D., discuss best practices in developing contamination control strategies through the lens of the newly formalized provisions in the EU GMP Annex I, Manufacture of Sterile Medicinal Products.


Advances In Piezo Mechanics Aid Eye Surgery

The article discusses recent advancements in piezo mechanics that are being utilized to improve precision and effectiveness in eye surgery procedures.

The Challenges Of Boomerang Projects In Micro Molding: A Customer Perspective

Boomerang projects in micro molding, where customers' projects return to the manufacturer for rework or modifications, present challenges due to design changes, quality issues, material-related challenges, and poor communication.

Surfactants Selection Guide For Lateral Flow Assays

For purposes of this study, three lateral flow tests were selected. Explore the effects of different surfactants on the performance of UniSart® diagnostic membranes.

Bio-Layer Interferometry (BLI) Systems For Quality Control

Explore the Octet® family of BLI systems that are used throughout biotherapeutic discovery, development, manufacturing, and QC workflows to simplify and streamline measurement of process and product attributes.


B. Braun provides an array of parenteral pharmaceutical solutions, including those for use in standard IV, irrigation, nutrition, and anti-infective therapy applications. The EXCEL® and PAB® containers and the DUPLEX Drug Delivery Systems feature biologically inert, PVC-Free and DEHP-Free, non-toxic plastic construction for a safe and accurate method of administering IV medication.

Caplugs has been a global leader in plastic molding with six different molding processes and thousands of material options. The in-house team of engineers works with customers throughout their comprehensive process to design a unique solution process from creating concepts and rapid prototyping to packaging and inventory management.

Cardinal Health’s OEM division offers a large selection of latex-free hydrogels in bulk rolls or in slit widths. These medical device hydrogels are used in a variety of applications including ECG signaling, defibrillation, electrosurgical and iontophoretic return electrodes, T.E.N.S., wound care, cosmetics, and non-skin adhesives.

Qosina offers the largest stock inventory of medical valves including check valves, relief valves, hemostasis valves, luer-activated valves, tuohy borst adapters and drain valves.

Canon's brushless servomotors are compact in size and provide high output power. Two types are offered with quick response and smooth rotation. Various custom options can be incorporated to fit your applications.

As the global life expectancy continues to get longer, the demand for electronic medical implantable devices is growing. Knowles offers a variety of capacitor solutions for the medical implant industry.


Dielectric Laboratories is a global supplier of microwave and millimeter wave components for optical and wireless communications, military, medical, semiconductor, aerospace, and transportation markets. We are a manufacturer of High-Q Multi-Layer capacitors (MLC) and Single-Layer capacitors (SLC), Resonators, Filters, Broadband DC blocks, Thin Film components, and Custom ceramic components. In 2004, DLI acquired Voltronics Corporation, a world leader in precision variable capacitors.




Artificial Intelligence and Machine Learning are taking the life sciences world by storm. Do you know how to harness its power for your medical device? Check out our latest e-book which examines the opportunities AI and ML offer to both complement and supplement human intelligence in the medical device industry.

More Content Collections