Innovations are helping companies to maintain compliance while driving operational gains across their supply chain.
Excessive focus on compliance can create hurdles in cultivating quality and innovation.
Manufacturers must re-evaluate existing regulatory and compliance strategies to meet the new requirements.
Throughout 2018, device and diagnostic manufacturers have opportunities to address challenging market trends and turn internal change into ways of increasing business and goodwill from providers who purchase their technology.
Human factor engineering must account for all groups within the Diffusion of Innovation curve. Medical devices must work for the Innovators, and more importantly account for the Majority Adopters and Laggards.
Technology should streamline the healthcare process for both patients and clinicians.
Held in November, the COMPAMED and MEDICA trade fair will showcase futuristic as well as tried-and-true medical technologies.
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.
There is still much to learn about the benefits and potential of robotic surgery.
The new MDR introduces several changes that manufacturers must consider right away.