European hedge rate for 2022
What is 1.2299?
Number of days before an audit start date when UCB and CRT audit registrations are due in CBW
What is 30 days?
Cost for UPS to ship a Confirmation Letter
What is 90 euros?
Document used to find what type of change needs to be reviewed
What is the Appendix D?
The individual responsible for performing the MDR Requirement Audit
Who is the Lead Auditor or Auditor with TA?
Form sent by TÜV SÜD America when utilizing subcontractors for a Non-MDR Audit
What is the MED_F_06.09 Contract for Intercompany Sub-Contracting?
Document required for all UCB and CRT registrations starting December 20th, 2021
What is the MHS Audit Planning Checklist?
TÜV SÜD America Sub-contracts this office to provide clients with Confirmation Letters
Who is the Munich Foreign Affairs Office?
The type of PSE project that must be opened for every Change Notice
What is a B021-515 project?
3 scenarios for when the Application Review Fee is applicable
What is an Initial MDR Certification Audit, Change Notice, or Certificate Renewal?
Length of time before a certificate’s expiry date wherein a Recertification Audit must be scheduled
What is six months?
Controlled document required for all registrations that will become obsolete on May 23rd, 2022
What is the MED_F_09.11 Company Profile?
Process owner for Unannounced Audits (UAA)
Who is Umesh Soni?
Used as the “PSE Model” when an application does not have an Application ID number
What is the date of the application signed by the client?
MED_T_03.118
What is the MDR: Non-Binding Quotation that is used for combination audits?
New rule for determining a client’s target month
What is certificate issuance date minus 3 months?
MHS-UCB Certification Body Manager
Who is Renee Walker?
General On-site and Off-site Mandays used to conduct an Unannounced Audit
What is 2 MDs On-site and 1.5 MDs Off-site?
Controlled document required by UCB any time a new certificate is to be issued
What is the UCB Audit Agreement?
Number of hours given to the Project Handler to review MDR Pre-Application forms
What is 40 hours?
3 individuals in the United States that are authorized to sign off on the financial order of a subcontract
Who is Neil Hall, Adam Menzies, and Joerg Vollner?
3 scenarios that would require a GCQ certificate to be issued
What is confirmation of scope statements, scope reductions, and changes to the manufacture (name or address)?
2 scenarios in which an Unannounced Audit must occur following an MDSAP audit
What is one of more nonconformities graded as a 5, or more than two nonconformities graded as a 4?
This section of PSE must be completed during project set-up if your Change Notice project involves the issuance of a certificate
What is the TC Check?
Material code used for an Initial MDR Certification of a Non-Active client
What is U14-158-10-PS0002?