Since June 2009, all drug listing submissions have been done electronically using Structured Product Labeling (SPL) files. Now, devices can be listed using SPL as well. While the FDA does not require that devices be listed using SPL, the ability to do is there, with benefits including providing product exposure on sites such as the National of Library of Medicine’s (NLM) DailyMed.
While regulators are understandably focused on compliance, industry needs to focus on quality. The terms are often used interchangeably, but there’s a big difference between quality and compliance. Think of quality as the processes, procedures, and culture that permeate an organization—enabling it to consistently develop and produce high-quality medical device products that will meet or exceed regulatory requirements.
The IEC has made a change to the Recovery Test, 60601-2-34. Issue 3 offers modifications that make it more beneficial for engineers as a custom test system is no longer required for this specific test. This article reviews the full breadth of the test and how it can impact medical device manufacturers.
As flexible manufacturing becomes a more attractive option to medical device manufacturers, ensuring that the processes involved with it all work in sync is critical. With leak testing in this system, there are a number of factors that need to be considered. This article reviews the areas that engineers need to keep in mind when adapting to this option.
Medical device engineers rely on an array of testing instruments and equipment to verify the safety and efficacy of their products. An axial-torsion testing system is just one of them; however, it has a variety of indications across various device sectors. This article looks at two products for which this testing instrument is invaluable.
Device manufacturers need to ensure their product will be sufficiently cleaned by healthcare professionals. This article will focus on the areas of the FDA’s guidance document that are causing difficulties in cleaning validations, and will demonstrate how pre-validation laboratory work can help save time and money.
Device testing is required for a wide array of variables in the development of a medical device. When it comes to devices used directly by the patient, however, it is critical to test the patient/device “relationship.” This article looks at examining and testing the human factor when it comes to the handling of a medical device and how the design can be improved to enhance that relationship.
The medical device industry is constantly changing. New technologies and products enter the market, replacing outdated or inefficient equipment. There are numerous benefits in using LEDs for medical illumination applications including longer life, less heat, dynamic control, lower energy consumption, and in many cases, lower cost.
Critically ill patients present a number of challenges to effective monitoring. Various disease states complicate blood chemistry, compromise perfusion, and cause fluctuating blood pressure levels, heart rates, body temperatures, available oxygen, and pH. Furthermore, the pharmaceuticals used to treat these conditions can skew body chemistry and vital signs, adding to the complexity.
Glenn Smith celebrates his 40th anniversary with global distributor Mouser Electronics as the company’s president and chief executive officer. Smith recently took a moment to discuss disruptive technologies, the electronics industry’s inevitable slowing, and how some companies still inconceivably refuse to embrace the internet.
Until recently, there was one method using dye to test for seal leaks in porous medical packaging. Now there are three methods manufacturers can select from for their product’s packaging. Which one should be used and why? This article attempts to tackle that question.
Cellular machine-to-machine communications are opening the door to a world of innovative new healthcare applications. With the ability to collect real-time data from people and devices anywhere, and at any time, healthcare organizations and technology vendors are creating useful applications that improve people’s health and well being.
There are many “hot button” issues that are of concern to medical device companies, such as infection control, the UDI rule, or the trend toward home healthcare. Since plastics are such a huge part of the design of medical devices, the molders who work with the OEMs are doing everything they can to address these same issues to help alleviate the challenges faced by designers.
Warehousing products can be a costly proposition for medical technology and device manufacturers. It requires leasing and management of a facility, as well as the overhead that goes along with that proposition. Using a warehousing provider can offer a more cost-effective and hassle-free way to fulfill orders.
The exciting growth the medical telemonitoring sector has seen recently is impressive. According to Frost & Sullivan, the industry is expected to exceed double the revenues of previous years. The reason for this growth is twofold: necessity and innovation.