EU
Robotics action plan for Europe
VDMA urges policymakers to boost competitiveness; Strategy paper sets out key objectives; Europe needs to accelerate in global AI and automation race.
More in EU
Closing the global product information gap
Regulatory affairs can fuel clinical and quality teams with key product information, help speed time to market, and be a catalyst for innovation. But the truth is most medtechs aren’t seeing these benefits, slowed down by inefficient administrative tasks.
Disruptive technologies taking the medical device industry by storm
The medical device industry is poised to benefit from greater agility and long-term efficiency savings.
EU IVDR clinical evidence requirements
New RQM+ paper highlights overlap in EU and US requirements to support efficient compliance.
RQM+ brings IVDR thematic search tool free to market
To help increase compliance efficiency, a new, freely available IVDR filtering tool is being offered to the market by RQM+.
EU MDR mandates require more than ad-hoc manual processes
How medical device manufacturers can make labeling operations compliant for European markets.
EU MDR postponement; FDA approvals
EU MDR compliance postponed one year; Manufacturing incident report solution for EU MDR report automation; Growing expandable orthopedic portfolio; Single-use micro-endoscopes
Are you EU MDR ready?
Trumpf image processing and cameras ensure quality management compliance of unique device identification requirements of the European Union Medical Device Regulation.
5 tips to EU MDR compliance
European Medical Device Regulation (EU MDR) brings significant changes to the medical device industry, with new classification rules topping the list.
Breakthrough Device Designation for NUsurface meniscus implant
Active Implants’s FDA Breakthrough Device Designation allows expedited review of first “artificial meniscus.”
