Manufacturers must re-evaluate existing regulatory and compliance strategies to meet the new requirements.
The DMR is nothing more than the recipe (a.k.a. secret sauce), while the DHR is documented evidence of compliance.
There really is no excuse for receiving a Form 483 observation for management review.
According to the Advocate General’s interpretation of the Directive and related soft law (i.e., MEDEV guidelines), software allowing the prescriber to detect contraindications, drug interactions and excessive doses shall qualify as a medical device.
The new MDR introduces several changes that manufacturers must consider right away.
The agency wants to modernize its regulatory processes and make them more efficient.
Going paperless can ultimately help companies focus on improving product quality and the end-user experience.
The settlement is one of a few that the company has made within the past several months.
The initiative also focuses on how devices will be regulated in the post-market world.
The new commissioner was confirmed in a 57 to 42 vote.