Medical Device Manufacturing: Five Challenges in Maintaining Compliance
The industry struggles with various unknowns that impact efficiency, quality, and as a result, finances. This article reviews some of these challenges and how to overcome them.
The industry struggles with various unknowns that impact efficiency, quality, and as a result, finances. This article reviews some of these challenges and how to overcome them.
Due to rapidly evolving regulatory landscape and manufacturing demands, label requirements and the information they contain are constantly changing. Here’s how medtech organizations can manage the process.
MedTech Intelligence recently sat down with Peter O‘Blenis, CEO of Evidence Partners to discuss challenges reviewers face throughout their literature review process in the context of regulatory compliance, and to talk about the upcoming virtual event, Evidence Matters 2021.
FDA also supports the removal of the HeartWare HVAD System from the market.
As the pace of innovation further accelerates in 2021, and the need to get new devices to market intensifies, maintaining adherence to regulatory controls is not enough.
A review of common risks and pitfalls of incorporating artificial intelligence in medical devices and an overview of the regulatory framework.
With only one month until the compliance deadline, many medical device companies still have much to prepare in order to meet the requirements.
Anyone can read the regulation. The challenge is in how to apply it to your company’s structure and product line.
Software continues to be a key factor in recalls, and this year the end of some EUAs may also contribute to an increase.
Labeling is as critical as quality for medical device products. If a manufacturer can’t shift labeling to meet production in an agile manner, their products may not reach their destination.