3 Essential Steps for First Article Inspection (FAI)

3 Essential Steps for First Article Inspection

First Article Inspection (FAI) is a process that verifies whether a new or modified production process conforms to the engineering drawings and specifications of a medical device. Verification of conformity helps with compliance and allows your project to move to full-scale manufacturing. In this article, we’ll look at three essential steps to maximise the FAI […]

Metrology Equipment Acquisition: 4 Essential Considerations

Metrology-Equipment-Acquisition-4-Essential-Consideration

With the increased value the MedTech industry is placing on high-quality metrology, many companies are considering upgrading their metrology equipment. Given the size of the investment and the challenges of vendor bias and over-specification, it’s essential to clearly define your requirements and get independent advice. The last thing you need is to spend money on […]

The Importance of Metrology and Inspection Gap Analysis for Medical Device Manufacturers

To remain competitive, compliant, and profitable, there needs to be a continuous drive for improvement in all elements of a medical device manufacturing operation. For example, there has been a push forward in recent years in the adoption of automation technologies as well as technologies that fall under the Industry 4.0 umbrella. There is the […]

What to Consider When Choosing a Dimensional Inspection Service Provider

What-to-Consider-When-Choosing-a-Dimensional-Inspection-Service-Provider

If you need dimensional inspection services, how do you choose a provider who will not only meet your requirements, but help you optimise and streamline your inspection and quality control processes? It’s an important question to consider, particularly in highly regulated industries like medical device manufacturing where components can be very small and have very […]

Using Advanced Metrology Solutions to Enhance Lean Manufacturing

Using-Advanced-Metrology-Solutions-to-Enhance-Lean-Manufacturing

Lean manufacturing involves eliminating or amending steps in a process that don’t add value. The aim is to improve efficiency, quality, and productivity using a systematic approach. The concept of lean has its roots in the automotive industry, where it was first introduced as a concept in the 1980s by Toyota. Today, lean principles are […]

Metrology Fixture Design Best Practice Overview

Metrology Fixture Design Best Practice Overview

The performance of metrology fixtures can have a major impact on the efficiency and productivity of your quality control processes. In industries like medical device manufacturing, this reality is amplified by compliance and safety requirements, as well as the tight tolerances that often apply. Therefore, it’s essential to follow metrology fixture design best practices. The […]