A risk-based approach to QMS. If you’re a manufacturer of medical devices, including the medical device portion of combination products this is not the first time you’ve encountered this emphasis; the shift towards Quality by Design (QbD) has placed risk assessment and management at the forefront of compliance and regulatory considerations for organizations operating within the life sciences industries. But ISO 13485:2016 and its quickly approaching requirements for certification have brought risk front and center for medical device manufacturers with a renewed urgency. Read more »

Change is an inherent part of the lifecycle of a medical device. It can affect all aspects of Current Good Manufacturing Practice (CGMP), from research and development to production and supply. Change management is a concept that ensures change is implemented in compliance with quality and regulatory requirements. It is the most critical element in a quality management system — inadequate change management creates a risk of non-compliance. Read more »

The Medical Device Tax has been a divisive issue since even before the Affordable Care Act (ACA) came into effect. Lobbyists for the medical device industry have repeatedly sought to have the tax repealed, arguing that it: Read more »

As a medical device manufacturer, you need growth and margins to be consistent. If either of these aspects are dwindling, then it may be time for you to reassess your business model. Read more »

The launch of a new medical device is a time of great excitement. After all, you’re creating something that could potentially improve or even save lives. While the documentation of a new medical device isn’t quite so exhilarating, it’s crucial to your success. Read more »

Using online platforms like Twitter, Facebook, Tumblr, LinkedIn, and others is a standard component of communicating with consumers in today’s business. And, it’s no different for drug and medical device manufacturers. In the life sciences industry, it’s even more critical to know how to communicate via social media, while still meeting regulatory standards. Here is some insight. Read more »

Every manufacturer must meet a set of design control regulations given by the FDA for each medical device they produce. An important part of the product manufacturing process, each of these design control requirements must be relevant to all devices, no matter how complicated or simple they are. Nevertheless, many manufacturers put too much emphasis on simply following the FDA’s regulations and not enough on actually understanding them – resulting in much longer product approval timeframes. Read more »

Risk management is one of the most important parts of the manufacturing process when it comes to developing safe, effective, and beneficial medical devices. Your company needs to implement risk management at all levels in order to create the kind of products consumers and regulators want, which shows just how necessary the process is. Read more »

For medical manufacturers, compliance with the FDA regulations is paramount, as the device or product itself as well as the manufacturing process must all meet these specific standards. With the rise in mobile medical apps in the past few years, there is a growing concern about the FDA’s regulation of these devices, and it is important for all manufacturers to understand which apps are to be regulated, why, and how. Read more »

For medical device managers, it is that time of the year when precautions should be especially considered. Medical products have international standards which must be complied with if these devices are to be internationally used and shipped. Most importantly, understanding and complying with ISO 14971 and its most recent version is necessary, and you must be prepared to lead your team in a risk evaluation that follows these standards. But first, what are the standards of the ISO 14971:2012 exactly, and what is it all about? Read more »