Overview of the role of Key Stakeholders in the Medical Device Regulations
The new MDR will apply across EU Member States from May 2020, under this regulation there are defined obligations which lie with the major stakeholders in the device lifecycle. The
Unique device identifiers (UDI)
This is a system by which medical devices are identified through their distribution and use. UDI information must be placed on the label and/or package of the device and will be bo
Understanding MDSAP
MDSAP (medical device single audit program) is an international program, which allows a single regulatory audit of medical device manufacturer’s QMS’ for the following regulato
KD&A – How Can We Help you?
KD&A provide expert medical device and IVD regulatory guidance to help launch products and access new markets. Our services include regulatory strategy, product registration for Au
International Medical Device Regulators Forum (IMDRF) Progresses
At a meeting held in Singapore the International Medical Device Regulators Forum (IMDRF) (initiated to carry out a similar role to the now disbanded Global Harmonisation Task Force
Some IVDs and Radiology devices to be exempt from FDA 510(k)
The FDA (US Food and Drug Administration) has announced plans to ease the pre-market notification, or 510(k), requirements for certain in-vitro diagnostic (IVD) and radiology devic
US Food and Drug Administration (FDA) Issue New Regulatory Guidance
The FDA has issued a new guidance to manufacturers detailing when to submit a new 510(k) for changes or modifications made to that manufacturer’s previously cleared medical devic
