EMA’s IDMP is not the pinnacle of data-based product/regulatory information management. It is simply the first in what will be a long line of digital requirements to emerge globally, across all facets of life sciences. This article reviews best practices for companies looking to maximize the ROI of their data-driven process transformation initiatives by making them more broadly fit for the future.
Automation handling with integrated controls can assist with laser marking for all shapes, sizes and materials used in the manufacture of medical devices. This approach can offer flexibility, along with the ultimate precision necessary, to support the UDI system, which provides a clear framework that defines the form in which information should be encoded on the device in accordance with its classification.
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.
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.
Timely compliance will ensure that your products will not be considered misbranded.
Sources of reliable data to continuously support claims of compliance by manufacturers will be in high demand in the future.
For too long this industry has lagged the pharma sector in terms of using data analytics to predict market trends. It’s time to change that.
By simplifying labeling compliance, companies can focus on better serving current and new markets.
Upgrading your enterprise labeling system could play a key role in ensuring compliance.