News

A Guide to Medical Device Risk Management & ISO 14971

Medical device risk management is rightfully an essential component of medical product design and development. When it comes to putting a product on the market, risk analysis is required by law, and regulation checklists must be followed thoroughly. These regulations are carefully outlined in ISO 14971 to...

15 Jul, 2021

Understanding the Role of Drug Delivery Systems in Medicine

The way in which a drug enters the body can have a vast effect on the efficacy of a drug, impacting where it is released, how much can be absorbed, and how long it remains in circulation. Innovations in methods of drug delivery have led many companies...

07 Jul, 2021

How Prototype Tooling Can Be a Smarter Alternative to Production Tooling

Tool selection is important to the medical device design and development and manufacturing processes, one that can make or break a project, and it’s not a cut-and-dry decision. There are actually three different types of tooling: prototype tooling, bridge tooling, and production tooling. Each type has its...

30 Jun, 2021

An Interview with Gilero’s Vice President of Quality & Business Systems

Kristin Benokraitis joined Gilero in 2007. As one of the team members who has been with Gilero the longest, she has had the unique opportunity to watch Gilero grow, and help fuel that growth, over her tenure with the company. Kristin herself has grown too, serving in...

28 Jun, 2021

The Importance of Proper Medical Device Labeling

What Is Medical Device Labeling? Medical device labeling refers to all of the information that is provided to the consumer with the device itself. This includes symbols, warnings, instructions, and control labels applied to the device or incorporated into the design by color coding, printing, machining, or...

18 Jun, 2021

Medical Device Design UX Workflow

UX workflows for medical devices are changing the healthcare industry. Adhering to a workflow that is user-focused is critical to maintaining this level of healthcare innovation. So what should a UX design workflow include, and how can designers keep users at the forefront? Let’s walk through how...

08 Jun, 2021

623 Medical Announces the Launch of Nüm, a Novel Sterile Topical Anesthetic Spray

MORRISVILLE, N.C., June 1, 2021 - 623 Medical has announced that their first commercial product, nüm, has been cleared by the FDA and is now available for sale in the US market. Nüm is a sterile topical anesthetic spray used to numb the skin prior to needle...

01 Jun, 2021

Gilero Raises Capital to Fuel Growth

MORRISVILLE, N.C., May 18, 2021 — Gilero, a contract design, development and manufacturing firm specializing in medical and drug delivery devices, has closed a round of growth capital to fuel the company’s strategic development plans. Gilero intends to use this funding to open new design centers in...

18 May, 2021