As Director of Regulatory & Quality for Creation Design Services, I continuously ask the question, “Is there value-add with the new UDI System?” The regulations to make medical devices safer and with the highest possible quality are constantly evolving. A good example of this has been the implementation of the Medical Device UDI System. The […]
Tag Archives | FDA
Today, it’s more common than ever for medical device OEMs to outsource significant portions of their design and manufacturing. The medical industry’s many regulations make this process especially complex. As Director of Regulatory & Quality for Creation Design Services, I’m often asked about our capabilities across the product life cycle from design through after-market support. […]
In the medical device industry, the reliability of a product is critical for patient safety. If a device has design flaws, missing due diligence documentation, or perceived gaps in compliance, an OEM’s credibility and ability to deliver a high-quality and safe product on deadline comes into question in the marketplace. At Creation, we understand the […]
These are exciting times to work in healthcare. With advancements in research and innovation, the medical device industry continues to push the envelope, saving lives and improving the quality of living for people across the globe. But even with all of the game-changing products that have been recently introduced such as LifeWatch’s Mobile Cardiac Telemetry […]
I had an opportunity to catch up with Jessica Crawford, President of New York-based MedTech, heading into the week of MEDTECH 2015. Jessica and I discussed today’s most significant opportunities and business challenges for bioscience and medical technology OEMs. Janelle Urchenko: Tell us more about the origins of MedTech. I understand it grew from […]
When it comes to medical devices, the subject of innovation is very complex. With drivers like government spending, a complicated regulatory landscape, the Internet of Everything and the personalized patient experience, there’s a lot to talk about. It’s no wonder that MEDTECH 2015 features a panel of experts discussing Manufacturing Innovation! We’re excited that Creation’s […]
Early in my career, a big part of my job was to coordinate company involvement in various trade shows across North America. I have worked hundreds of industry and association events over the years. As a result, most tradeshows and conferences can look the same to me and I rarely get excited to attend. However, […]
The Internet of Things and wirelessly connected medical devices are transforming healthcare.
At Creation, a core element of our Purpose is enriching lives. Some days, we even get to save them.
Manufacturing FDA-approved medical devices requires preparation, expertise and commitment. Here are three considerations when evaluating your process.