DOCU Whitepapers

We are less than one year away from the full implementation of the European Union Medical Device Regulation (MDR) (May 2020) and three years away from the full implementation of the In Vitro Device Regulation (IVDR) (May 2022).

Adopting ISO 80369

Clear high-barrier materials are an excellent alternative to traditional aluminum foil. Manufacturers enjoy the ability to easily inspect packaged product through the use of vision systems, metal detectors, and manual visual inspection. As a marketing tool, clear materials allow for product differentiation

The purpose of this white paper is to highlight potential threats in typical modern medical applications in terms of cybersecurity and protection of patients' medical data, and how to effectively address these threats with Intertrust's whiteCryption® technology.

Successful part designs and material selection are built on an understanding of potential process-related issues such as the potential for warpage – thus, it is very important to understand the causes of warp in order to avoid this defect!

A global OEM and longtime Crescent Industries customer needed a customized, automated, and high-throughput solution to capitalize on a successful product—and they needed it fast. As demand for its reagent dipstick exploded due to rapidly increasing market share, this OEM struggled to supply hospital labs with

When developing a new product using injection molding processes, the customer wants to achieve specific levels of product performance. The manufacturer wants to have a certain level of production efficiency. The end user wants to have reliable performance of the product in the field.

Many companies think the purchasing of an injection mold is the tooling necessary to produce a plastic part, while this is correct there are some considerations that need to be made before your purchase.

This white paper discusses the need for pressure sensor integration in medical devices with a focus on applications, different pressure sensing technologies, MEMS sensor options, and considerations during the encapsulation and integration process. It highlights the need for an experienced partner to help stre

When medical device and diagnostics manufacturers work through material selection for their products, polymers such as polycarbonate (PC), polyethylene terephthalate (PET), and poly-vinyl chloride (PVC) are commonly used materials that first come to mind. Some of these established grades are used because t

The viability of new interventions dependent on more robust componentry

Today's hemostasis valves are a vexingly difficult engineering challenge. Beyond the minimum requirements per ISO 11070 and ISO 10555 for pressure and vacuum decay, emergent invasive catheter therapies are demanding muc

The high stress of an emergency room or ICU creates an environment in which the probability of human error spikes dramatically, adding a layer of risk to an already-tense situation. Asking medical professionals to make rapid diagnoses and decisions in that stress-filled state can lead to device misconnection,

This white paper details the benefits of ZPower's rechargeable microbatteries for designers and engineers aiming to create new and disruptive products. ZPower's rechargeable cell is the smallest, high-energy microbattery available to innovators looking to shrink the next generation of consumer & medical produ

This FAQ covers the major benefits of ZPower's silver-zinc microbatteries. ZPower batteries are the smallest, safest, highest-energy rechargeable microbatteries available. They are a good choice for designers and engineers aiming to enable new, next-generation smaller and safer consumer and medical products.

SanaVita Medical manages reverse-engineering, reduces time to clinical evaluation for spinal tether implant.

Medical device packaging and sterilization validation are required for FDA 510(k) submissions yet are often causes of delay. Sterile packaging validation is a vastly misunderstood topic in its own right but becomes even more complicated when considering it involves the additional coordination of manufacturing

Historically, human factors risk has taken a back seat to clinical risk. For a product to be viable it needs to clinically work and used as intended in a safe and effective way.

By not focusing on mitigating risk on both fronts, there remains a chance that the safety of patients, doctors, nurses

In this paper, we will focus on only one very small aspect of this investigation revealed in several articles, which has relevance to the medical device risk management process of both the hardware and the software system, as it relates to cases the author has encountered in the medical device industry.

Die attach adhesives serve a vital role in semi-conductor assembly, manufacturing and throughout the product life cycle. In this white paper, learn how they facilitate assembly and about the application process. Find out why thin bond lines are so important for product life cycle. Bond strength is only one, a

Is it time to ask for a raise? Each year, we ask medical device and diagnostic industry professionals detailed questions about their compensation and careers. This year, 245 full-time medtech professionals sent in responses. We've analyzed the data to reveal the median salary for the industry as well as ga