News

An Introduction to Human Factors Engineering

Human factors engineering is a design approach focused on optimizing the interactions between users and devices. Also known as ergonomics or usability engineering, human factors engineering (HFE) can be applied to hardware, software, and a variety of complex systems. This aspect of design development is meant to...

26 Sep, 2021

An Interview with Gilero’s Vice President of Technical Operations

Eli Nichols is the VP of Technical Operations at Gilero, where he uses his extensive engineering background and breadth of medical device knowledge to oversee Gilero’s design transfer team. Learn more about why Gilero has a dedicated team for transferring designs into manufacturing, and Eli’s role in...

15 Aug, 2021

Understanding 21 CFR Part 211

What is 21 CFR Part 211? The Code of Federal Regulations Title 21 Part 211 refers to the current Good Manufacturing Practices (cGMPs) set by the FDA for finished pharmaceuticals. These requirements are meant to ensure that finished drug product is handled in a way that does...

10 Aug, 2021

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