Knowledge Management
This initiative focuses on building, sharing, and transferring knowledge within the function.
What is Knowledge Reinvestment?
This authority is responsible for RF approval in all 50 US states and the 7 US territories with a permanent population.
What is the FCC?
This is the SAP module that Medtronic uses to control product distribution.
What is GTS (Global Trade Services)?
Amendment to the EU MDR Regulation extending AIMD/MDD certificate validity.
What is Regulation (EU) 2023/607?
At the end of their TDI event, the TYRX team engaged in this interactive activity, often used at social gatherings to break the ice and encourage participants to mingle.
What is a human bingo game?
In Knowledge Reinvestment, there are three critical ways of knowing/learning: Explicit, implicit, and this third type.
What is Tacit knowledge?
This group consists of Operating Unit and Geographical Business representatives, handling radio- and telecommunications compliance.
What is the Radio Frequency Working Group?
This is the tool that is replacing the Regulatory Release Authorization (RRA) form.
What is the GTS License Request Intake Tool?
Current UKCA transition topics can be found on this internal site.
What is Developedia?
During their last TDI, the GRS team made a reference to this iconic Karate Kid character known for his wisdom and guidance in martial arts.
Who is Mr. Miyagi?
This is the name of the online SharePoint developed by Regulatory Affairs to store and index information into a single online repository.
What is the Knowledge Reinvestment Filing Cabinet?
This category of radio apparatus meets prescribed standards without needing a Technical Acceptance Certificate or submission to a CB for ISED Canada.
What is Category II equipment?
This is the name or acronym of the change order used to assess regulatory impact for a new product.
What is Regulatory Assessment – New Product (RAN)?
The MAP Agile Master Collection number for EU MDR extension letters.
What is CTN00040972?
This is the name of Rita's canine companion, a small moniker for a beloved pet.
Who is Minne?
This is the number of major topics (drawers) in which the Knowledge Reinvestment Filing cabinet is organized.
What is TEN?
This license allows clinical devices with Radio Frequency to operate without an FCC grant at a specific location.
What is a Site Experimental License/Medical Testing License?
Name two submission types currently supported by the FDA eSTAR Form.
What is 510(k), DeNovo, PMA-S Panel Track, PMA-S 180DN, PMA-S RTR, Original PMA (Not Modular), Pre-Submissions and 513(g) submissions utilize the Pre-Submission eSTAR form (i.e., PreSTAR)?
ISO standard for sterile packaging.
What is ISO 11607?
This agency is responsible for assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, the nation's food supply, cosmetics, and products that emit radiation.
What is the FDA?
This exercise was used to brainstorm, map and prioritize Tip Card topics in Regulatory Affairs.
What is the Tip Card Post-It Exercise?
Name one of the procedures for assessing conformity under the Radio Equipment Directive.
What are Internal Production Control, EU Type Examination, and Full Quality Assurance?
This is the certificate issued for the export of legally marketed devices in the United States that are in compliance with the requirements of the FD&C act.
What is the Certificate to Foreign Government (CFG)?
Medical devices, including custom-made devices, compliant with the EU MDR can be placed on the Great Britain market up until what date.
What is June 30, 2030?
This web-based system supports the tracking and management of changes, submissions, and model-specific attributes.
What is CATS?