FAIs: When do you use conventional versus digital inspection methods?

Tony Holtz, Proto Labs First article inspections (FAIs) can be time-consuming and costly, but they are a necessary step in getting medical devices from product design to production. Medical device manufacturers are likely familiar with the process, although most leave it to suppliers to handle. Even if that is the case, device makers should get

Medtech complaint handling: Is there something to complain about?

Medtech complaint handling appears to be a work in process, according to Sparta Systems’s recent quality management market survey. The 2017 survey – which had 148 respondents in highly regulated industries including medical devices (23%) – found that nearly a quarter of those who answered did not have a well-defined and adopted complaint handling process. Only

Validation: 8 things you need to know

Validation of manufacturing processes is extremely important, given our highly regulated environment. Here’s a primer to get you started on the subject. Steve VanderKooi, Kyle Kulwicki, Kevin Roberts, PTI Engineered Plastics Validation uses objective evidence to prove that a process is capable of consistently producing a product that meets pre-defined requirements, including customer and user needs, functional

Serious medical device recalls nearly doubled in Q2

Medical device recalls at the Class I level were up 88% during the second quarter of 2017, and the major culprit was quality issues involving device part malfunctioning, according to a new report from Stericycle ExpertSolutions. Quality played a significant role among the 15 serious medical device recalls during the second quarter, partly because it encompasses such

How cleanrooms can ensure life science product quality

Cleanrooms are an important production tool for life sciences manufacturers; maintaining high stands of product quality ensures product efficacy and builds a strong reputation. Kevin Weist, president, Clean Air Products Quality is paramount in the life sciences. The innovation and growth for which life sciences companies strive cannot be attained without top quality products. Whether

Freudenberg Medical implements SAP platform and global quality system

Freudenberg Medical, a global developer and manufacturer of medical devices, components, and minimally invasive solutions for the medical device industry, has announced the global implementation of SAP.  This three-year multi-million dollar investment is backed by IT support from the Freudenberg Group with a long history of successful SAP integration.  Freudenberg Medical can now offer customers

Medical device requirements management: Here’s what it is

Rebecca Haag and Gary Seim, Minnetronix The total number of requirements for a project is generally correlated with the complexity of the system under development (i.e. how many functions and qualities it needs to have). For even moderately complex projects, this can become overwhelming. It can be difficult to keep track of where specific requirements

QMS compliance: Here are the basics

Rachel Beavins Tracy, Verse Solutions U.S. FDA requires companies to validate any software used in design, manufacture, packaging, labeling, storage, installation and servicing of finished devices. Companies must also use change control to ensure changes to IT systems don’t create unintended risks. But meeting FDA requirements around software validation and change control isn’t always straightforward,

No management support is common QMS audit problem

By Stewart Eisenhart, Emergo Group Undergoing an audit from a third party or conducting your own inspection of your medical device quality management system (QMS) can be a complex process with many moving parts—any of which can go wrong if not carefully monitored. Over a series of blog posts, we’ll discuss various common problems that

Quality management: the surprisingly happy solution

Rachel Beavins Tracy, EtQ In Shawn Achor’s bestselling The Happiness Advantage, he describes how the traditional idea that success leads to happiness is completely backward. He tells us that in reality, it’s happiness that breeds success. Throughout the book, he points to endless numbers of studies showing that everyone from financial managers to factory employees

MasterControl and Lorenz: Here’s how they’ve streamlined document management

MasterControl, a provider of enterprise quality management systems, and Lorenz Life Sciences Group, a regulatory information management solutions provider, have a decade of joint success when it comes to customers streamlining and integrating their document and submission management services. “Integrating with an industry leader, MasterControl, has been providing a seamless way for customers to drag-and-drop

Keystone Electronics expands and moves N.Y. warehouse

Keystone Electronics has moved its warehouse and quality control lab to a new state-of-the-art facility in New Hyde Park, N.Y. This new fulfillment center incorporates Keystone’s finished goods inventory as well as its Quality Control lab and staff. The facility is a U.S. Green building, having achieved Gold Level LEED Certification from the U.S Green

U.S. medical device approvals: Pitfalls you need to avoid

Companies that are strapped for time and cash would do well to understand exactly what the agency wants and avoid unnecessary pitfalls, says Michael Lynch, managing consultant at Intertek. (Lynch will be presenting a straightforward webinar on Jan. 31, at 2 p.m. Eastern time: “5 Steps to Medical Device Commercialization in the U.S.”) “FDA is

Star Wars medtech lesson: Rogue documents led to Empire’s downfall

Warning: This story is filled with terrible Star Wars references. Management would like to apologize in advance. In our defense, David Butcher at MasterControl started it —the story comes from his original post.  When Rogue One: A Star Wars Story arrives in theaters this week, we will learn how the Rebel Alliance brought down the Death Star

MasterControl reports innovation and continued growth

MasterControl, a leading global provider of enterprise quality management systems (EQMS) and quality and compliance consulting services, says it has experienced a stellar year in terms of company growth and customer success and delivering new advancements to the market. “If I had to categorize the scope of 2016 for MasterControl, I would call it a