White Papers for Medical Device Industry Suppliers

The FDA has announced plans to transition to standard ISO 13485:2016 for medical devices in April 2019. In addition, the Medical Device Single Audit Program, MDSAP, has gained traction with full implementation set for 2019. Download this paper to learn more about these two changes from the...

We often get asked: “Do I need a test protocol?” or “How do I develop one?” This document outlines the common sections of a protocol. We highly recommend having test protocols in place prior to starting any study and will work with you to develop your testing strategy.

The plastics pyramid below is an at-a-glance plastic material selection guide. Every application has unique material characteristic requirements for temperature, strength, cost and more. We use the broadest range of injection molding plastic resins, including commodity, engineering and...

Retroactive development of approval documents apartis produced the FDA-approval documentation in accordance with 510(k) and 21CFR, part 11 for medical equipment software that had been developed previously. We developed and executed missing software validation test cases and created a trace...

Postpartum hemorrhaging is a major cause of maternal mortality in the developing world. The condition requires immediate medical treatment and transfusion with appropriate blood products. Accessing a blood supply might be straightforward in an urban hospital but in the rugged rural terrain of...

Today more value is being placed on the enhancement of medical devices through miniaturization and added capabilities such as pressure sensing components. Proper integration of a MEMS pressure sensor in a medical device requires in-depth knowledge of sensor types, capabilities, validation and...

TENSIONING – GEARING - CAMMING - In this article we will review three widely used motion control techniques: web tension control, proportional material spacing, and CAM-based synchronized profiling.

Patient safety depends on it!

Leakage current testing is the measurement of electrical “leakage current” that results from powering an electrical appliance via mains or dc power. Leakage current is the unwanted or unintended flow of electrical current that presents an electrical hazard such as shock or burn.

Miniature solenoid valves are critical components in portable life science equipment. Beyond the necessary long service life, medical, analytical, and point-of-care devices often require pneumatic systems with high flow rates, compact footprints, and low power consumption. Specifying solenoid...

Urethane casting can be ideal for quantities up to about 25 parts, and it has several advantages over other plastic manufacturing processes like injection molding and additive manufacturing (3D printing).

People turn to AdminiSMART for help on everything relating to managing employees. This includes everything from payroll and HR technology, to HR consulting, to benefits, to managing unemployment and much more. Our clients work with us because we only bring in best in class solutions from fully...

Quality is the #1 concern for OEM engineering and purchasing managers in all industries, but nowhere is quality more critical than in the manufacture of medical devices. This guide is intended to help medical device manufacturers evaluate the level of quality in their metal stamping suppliers,...

Cryogenic valves are vital in the medical and aerospace industries, as well as within our food supply chain. Because of their importance, using the proper valve correctly is essential for maintaining your application's reliability and performance.

When asked about the most basic goal of nearly any business, most will give the same answer: maximize revenue while minimizing costs. You may not realize it, but inefficiencies and issues within your supply chain might be eating a big chunk of your profits each year. Thousands or even millions...

Low pressure (.2 to 5 psig) is one of the most rapidly growing segments of the pressure measuring market. It is, unfortunately, very difficult to make accurate calibrations of high accuracy gauge pressure instruments in this range. This paper discusses some problems and solutions found in making...

One common question about surface treatment systems is, “What is the difference between corona and plasma, and what best fits my application?” Both corona and plasma treatment increase the surface energy of materials and thereby improving the adhesion of inks, adhesives, flocking or other...

Jordi Labs determines extractables and leachables in polymeric materials.

A SINGLE UNIT DOSE NASAL SPRAYER CARTON FOR FLU VACCINE PROVIDES A MORE COMPACT AND LOWER COST ALTERNATIVE TO BLISTER PACKAGING

Customer engaged MME group for tooling and production molding work for two of 37 total parts required to manufacture a popular consumer product, the number one walking cane in America. MME group provided contract manufacturing solutions for the customer to move its entire offshore production to...

Modern Vapor Degreasing Systems are Environmentally Friendly, Save Energy

Machining with reclaimed Carbon Dioxide (CO2) addresses two critical issues in the medical machining industry. The first issue is the need to machine components that are designed to be used inside the human body where part contamination introduced during the machining processes is prohibited....

Medical device product liability lawsuits are a stark reality in the manufacturing industry. The nearly doubling of medical device recalls in the past decade proves that even with the FDA working to ensure that only “safe” products are made and manufacturers making a dedicated effort to...

The landscape of today’s clinical trials is ever changing, posing greater challenges for sponsors, investigators and FDA alike. Challenges include increased complexity, novel therapies, large multi-site trials, inclusion of vulnerable patients, trials conducted outside of the United States, and...

The electronic, high-tech, semiconductor, pharmaceutical, aero space, medical and many other industries depend on cleanroom technology. As products such as cell phone circuit boards become smaller, the chance of contamination in manufacturing becomes higher. For pharmaceutical companies, clean,...