Achieving EU MDR compliance is considerably challenging for many businesses, which is why they must be discerning when it comes to selecting suitable partners.
One ill-prepared EO can impact the entire supply chain.
A recap of a recent effort involving a small group of AIDC experts in devising a data integrity scheme suitable for protecting a new device identifier used in modern healthcare applications against mis-keying. It presents the group’s undertakings in researching solutions to ensure identifier integrity, the challenges encountered, and how a more complete understanding of the constraints of the intended application led to a departure from the initial design and resulted in the elegant solution that exists today.
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.
With May 26, 2020 quickly approaching, every day counts.
Label and packaging artwork processes play an important role in meeting compliance for EU MDR.
The certification comes at a time when many companies have been saying that the May 2020 deadline is too soon.
The first critical step in being able to feel confident about your clinical evaluation reports (CERs) is to ensure you know exactly what they entail.
Here’s what companies think when it comes to how much it will cost to comply with the new regulation.
After one year into the transition period, it is clear that manufacturers are not where they need to be in meeting the compliance deadline.