Digital transformation is especially important to medical device manufacturers because they must have good quality data, and especially tracking metrics, to track complaints and device performance to comply with regulatory requirements. And these requirements are just getting stricter.
Anyone can read the regulation. The challenge is in how to apply it to your company’s structure and product line.
Although medical device manufacturers have more time to prepare due to the delayed EU MDR deadline, this shouldn’t distract from the extensive documentation they must compile in the meantime to prove their devices are compliant.
As the proliferation of connected and complex medical devices grows, healthcare providers are more susceptible to cyberattacks.
Make sure your 510(k) submissions pass with flying colors. Explore the latest regulations impacting bacterial endotoxin testing.
The latest regulations for human and veterinary medicinal products, as well as medical devices, include the mandate to set up databases with detailed information about available products. These databases must be realized and implemented in the near future, and require a concerted effort now if tangible real-world benefits are to follow.
Artificial intelligence and machine learning technologies have significant potential, but regulatory hurdles may stand in their way.
Do regulators have a disincentive to approve medical devices?
The new PMD Act was based on previous ordinances implemented in the summer of 2014. Two of the main points of this revision are to increase safety measures for medical devices and introduce new cellular and tissue therapeutic product regulations.