Scheduling / Quoting & Subcontracting
Registrations, Submissions, & Certificates
Foreign Affairs & Unannounced Audits
Change Notices & Special Audits
MDR
100

European hedge rate for 2022

What is 1.2299?

100

Number of days before an audit start date when UCB and CRT audit registrations are due in CBW

What is 30 days?

100

Cost for UPS to ship a Confirmation Letter

What is 90 euros?

100

Document used to find what type of change needs to be reviewed

What is the Appendix D?

100

The individual responsible for performing the MDR Requirement Audit

Who is the Lead Auditor or Auditor with TA?

200

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?

200

Document required for all UCB and CRT registrations starting December 20th, 2021

What is the MHS Audit Planning Checklist?

200

TÜV SÜD America Sub-contracts this office to provide clients with Confirmation Letters

Who is the Munich Foreign Affairs Office?

200

The type of PSE project that must be opened for every Change Notice

What is a B021-515 project?

200

3 scenarios for when the Application Review Fee is applicable

What is an Initial MDR Certification Audit, Change Notice, or Certificate Renewal?

300

Length of time before a certificate’s expiry date wherein a Recertification Audit must be scheduled

What is six months?

300

Controlled document required for all registrations that will become obsolete on May 23rd, 2022

What is the MED_F_09.11 Company Profile?

300

Process owner for Unannounced Audits (UAA)

Who is Umesh Soni?

300

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?

300

MED_T_03.118

What is the MDR: Non-Binding Quotation that is used for combination audits?

400

New rule for determining a client’s target month

What is certificate issuance date minus 3 months?

400

MHS-UCB Certification Body Manager

Who is Renee Walker?

400

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?

400

Controlled document required by UCB any time a new certificate is to be issued

What is the UCB Audit Agreement?

400

Number of hours given to the Project Handler to review MDR Pre-Application forms

What is 40 hours?

500

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?

500

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)?

500

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?

500

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?

500

Material code used for an Initial MDR Certification of a Non-Active client

What is U14-158-10-PS0002?

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