The medtech regulatory environment in Europe has entered a new era. A Europe-wide medical device regulation has come into effect, presenting both challenges and opportunities for stakeholders in the sector.
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.
For pharmaceutical and medical device manufacturers, computerized systems validation is vital. The following are three areas businesses must fine tune to ensure computerized labeling systems meet the stipulations of the new GxP regulations.
The exemption reduces the regulatory burden on the medical device industry—including the time and costs involved in preparing, submitting and responding to requests for additional information.
It’s time to consider CAPAs as opportunities rather than just other issues to tackle.
Moving too quickly in the product development process can lead to mistakes.
All industries under the healthcare umbrella should embrace each other’s capabilities because no single category of player can master it and bring to consumers all that we need and demand, says Stephen Bernstein of McDermott Will & Emery.
Companies can improve their chances for a successful transition by leveraging their knowledge of their medical devices and understanding what each device’s categorization under the MDR means to its testing strategy.
Operating with an antiquated QMS raises your risk. Here’s what to consider when modernizing your system.