TUV SUD EXAM QUESTIONS WITH COREECT ANSWERS LATEST UPDATE 2025
Role for each reviewer - Answers AR - Review for application submission file.
LTR - Review of the submission file for the purpose of quality assurance.
STC - Certification review and Make decision.
What are the three cert types we provide - Answers MDSAP - Q56
ISO 9001-QS5
ISO 13485- QS2
Vacation code - Answers PCD
sick time code - Answers B021-100
What are the two things we need to check when providing certs? - Answers sites and standards
What do we do when we complete admin review? - Answers Complete Survey (found in Quad Squad in
Teams)
What is the MHS Uploader responsible for? - Answers to submit a project and upload documents
What is a Project Handler? (PH) (3 parts) - Answers (solves problems),
a) Fills out/ checks what was inserted into the system and requests change if needed
b) inform class of medical products
c) manage corrections, action items, clarification requests from LTC and STC
What does LTC and STC stand for? - Answers
What are the responsibilities of Admin Review? - Answers to evaluate delivered docs in surveillance
processes, judge if projects shall be archived, rejected, revised, approved
If there any changes/suggestions/problems/error messages what should you do? - Answers Report in
detail including Project #, Customer Name, part of the process that is affected, and target your comment
What documents in Roxtra have the instructions and details of these Medici processes? - Answers
909.02, 9.32, 9.17, 1.02, 9.09
Application Review - Answers Application review is required for certain projects (e.g. initial certification
or changes that include a scope expansion).
The conformity assessment will start only once the application review has been positively closed and
approved by the certification board.
,QS Submission (Audit) - Answers In case of all applicable audits (e.g. initial audit, surveillance audit,
recertification audit, combination audits including several standards).
TD Assessment on a representative basis - Answers In case the conformity assessment procedure
requires the assessment of the technical documentation on a representative basis and the related audit
or change notification need to be uploaded in separate submissions and linked afterwards.
Full TD Assessment - Answers In case of the conformity assessment procedure requires a full TD(tech
documentation) assessment.
For product certificate
This can be linked to separate projects (e.g. application review, change notification).
Extension of Certificate - Answers The product- and QS-extensions which require a TD (technical
documentation) assessment. But, for recertification audits refer to QS submission (Audit).
Change notification - Answers If an audit, TD(tech documentation) assessment or renewal of certificate
includes the evaluation of a significant change, the change submission shall be created as a separate.
Updated PSUR, SSCP, SSP (Periodic Safety Update Report, Summary of Safety and Clinical Performance,
Summary of Safety and Performance) - Answers In case a project leads to an update of PSUR/SSCP/SSP
of an already certified product (e.g. renewal, change notification, TD assessment of implantable devices)
it is required to submit a separate file in parallel to the original project to cover SSP, SSCP, or PSUR.
EC Submission - Answers Until the end of the transition period, audits and TD (Technical Documentation)
assessments can still be submitted to MEDICI under AIMDD/MDD/IVDD.
Special Project - Answers This section refers to the discontinuation of certification which are submitted
as 'special projects' to MEDICI.
(e.g. cancellations by the certificate holder or TÜV SÜD PS, conditions, hearing
letters/suspensions/withdrawals/reductions and withdrawn or refused applications for certification.)
Change of CBW Metadata - Answers In case of CBW metadata needs to be changed without changing
the printed certificate content.
This can be linked to submission to e.g. an audit, TD assessment, renewal or change notification.
For further details when CBW metadata needs to be changed refer to MED_W_10.08.
What are the projects implemented in Medici? - Answers QS (Quality system certificate), PC (Product
certificate), etc.
Use of the submission index is usually done according to the indication written in the file. Generally, -
Answers 1. Open the selected Submission index (excel file).
, 2. Select the correct 'type of project' in the 'Please select' space.
3. Select all applicable certification criteria in the 'Possible certification criteria' space.
4. Click on the 'Refresh' button.
The project team consists of - Answers CARE, PH, LA, PC, Commercial Assistant, TDA, PS...
In the year 2021, Project 'Surveillance audit for MDR (G10 type) and ISO 13485 (Q5 type)' was
performed, and the project file will be uploaded to the MEDICI. In this case, please select all applicable
types of project submissions to be submitted to MEDICI. - Answers TD Assessment on a representative
basis, QS Submission (Surveillance Audit)
In the year 2021, Project 'Initial Certification audit for MDR (G10 type certificate) and ISO 13485 (Q5
type certificate)' was performed, and QS submission file for Initial Certification audit and file for TD
Assessment on a representative basis shall be uploaded to the MEDICI. In this case, which of the
following submission indexes should be used? Please select all relevant submission indexes. - Answers
MEDW1006.01, MEDW1006.02
What are the different review processes? - Answers 1. Application review
2. Certification review
3. Surveillance review
4. Review of TD assessment on a representative basis
5. Review of PSUR review or Clinical consultation review.
Independence and Impartiality, 4-Eye Principle (MED_P_09.09): - Answers Reviewers shall conduct
reviews only for projects where they were not involved in assessment activities. However, Application
review, local technical review, final review and decision are not regarded as participation in the
assessment.
Example: It is acceptable if a STC does final review for a project where the same STC previously did
application review and/or local technical review.
Feedback (MED_W_10.10, See '5A Book' in this training). - Answers (MED_W_10.10, See '5A Book' in
this training).
Risk Based Approach - Answers In this case it may be considered if the following options can allow
release despite formal errors or gaps.
1. Additional surveillance
2. Conditions on certification
3. Issue certificate with limitation of use
Role for each reviewer - Answers AR - Review for application submission file.
LTR - Review of the submission file for the purpose of quality assurance.
STC - Certification review and Make decision.
What are the three cert types we provide - Answers MDSAP - Q56
ISO 9001-QS5
ISO 13485- QS2
Vacation code - Answers PCD
sick time code - Answers B021-100
What are the two things we need to check when providing certs? - Answers sites and standards
What do we do when we complete admin review? - Answers Complete Survey (found in Quad Squad in
Teams)
What is the MHS Uploader responsible for? - Answers to submit a project and upload documents
What is a Project Handler? (PH) (3 parts) - Answers (solves problems),
a) Fills out/ checks what was inserted into the system and requests change if needed
b) inform class of medical products
c) manage corrections, action items, clarification requests from LTC and STC
What does LTC and STC stand for? - Answers
What are the responsibilities of Admin Review? - Answers to evaluate delivered docs in surveillance
processes, judge if projects shall be archived, rejected, revised, approved
If there any changes/suggestions/problems/error messages what should you do? - Answers Report in
detail including Project #, Customer Name, part of the process that is affected, and target your comment
What documents in Roxtra have the instructions and details of these Medici processes? - Answers
909.02, 9.32, 9.17, 1.02, 9.09
Application Review - Answers Application review is required for certain projects (e.g. initial certification
or changes that include a scope expansion).
The conformity assessment will start only once the application review has been positively closed and
approved by the certification board.
,QS Submission (Audit) - Answers In case of all applicable audits (e.g. initial audit, surveillance audit,
recertification audit, combination audits including several standards).
TD Assessment on a representative basis - Answers In case the conformity assessment procedure
requires the assessment of the technical documentation on a representative basis and the related audit
or change notification need to be uploaded in separate submissions and linked afterwards.
Full TD Assessment - Answers In case of the conformity assessment procedure requires a full TD(tech
documentation) assessment.
For product certificate
This can be linked to separate projects (e.g. application review, change notification).
Extension of Certificate - Answers The product- and QS-extensions which require a TD (technical
documentation) assessment. But, for recertification audits refer to QS submission (Audit).
Change notification - Answers If an audit, TD(tech documentation) assessment or renewal of certificate
includes the evaluation of a significant change, the change submission shall be created as a separate.
Updated PSUR, SSCP, SSP (Periodic Safety Update Report, Summary of Safety and Clinical Performance,
Summary of Safety and Performance) - Answers In case a project leads to an update of PSUR/SSCP/SSP
of an already certified product (e.g. renewal, change notification, TD assessment of implantable devices)
it is required to submit a separate file in parallel to the original project to cover SSP, SSCP, or PSUR.
EC Submission - Answers Until the end of the transition period, audits and TD (Technical Documentation)
assessments can still be submitted to MEDICI under AIMDD/MDD/IVDD.
Special Project - Answers This section refers to the discontinuation of certification which are submitted
as 'special projects' to MEDICI.
(e.g. cancellations by the certificate holder or TÜV SÜD PS, conditions, hearing
letters/suspensions/withdrawals/reductions and withdrawn or refused applications for certification.)
Change of CBW Metadata - Answers In case of CBW metadata needs to be changed without changing
the printed certificate content.
This can be linked to submission to e.g. an audit, TD assessment, renewal or change notification.
For further details when CBW metadata needs to be changed refer to MED_W_10.08.
What are the projects implemented in Medici? - Answers QS (Quality system certificate), PC (Product
certificate), etc.
Use of the submission index is usually done according to the indication written in the file. Generally, -
Answers 1. Open the selected Submission index (excel file).
, 2. Select the correct 'type of project' in the 'Please select' space.
3. Select all applicable certification criteria in the 'Possible certification criteria' space.
4. Click on the 'Refresh' button.
The project team consists of - Answers CARE, PH, LA, PC, Commercial Assistant, TDA, PS...
In the year 2021, Project 'Surveillance audit for MDR (G10 type) and ISO 13485 (Q5 type)' was
performed, and the project file will be uploaded to the MEDICI. In this case, please select all applicable
types of project submissions to be submitted to MEDICI. - Answers TD Assessment on a representative
basis, QS Submission (Surveillance Audit)
In the year 2021, Project 'Initial Certification audit for MDR (G10 type certificate) and ISO 13485 (Q5
type certificate)' was performed, and QS submission file for Initial Certification audit and file for TD
Assessment on a representative basis shall be uploaded to the MEDICI. In this case, which of the
following submission indexes should be used? Please select all relevant submission indexes. - Answers
MEDW1006.01, MEDW1006.02
What are the different review processes? - Answers 1. Application review
2. Certification review
3. Surveillance review
4. Review of TD assessment on a representative basis
5. Review of PSUR review or Clinical consultation review.
Independence and Impartiality, 4-Eye Principle (MED_P_09.09): - Answers Reviewers shall conduct
reviews only for projects where they were not involved in assessment activities. However, Application
review, local technical review, final review and decision are not regarded as participation in the
assessment.
Example: It is acceptable if a STC does final review for a project where the same STC previously did
application review and/or local technical review.
Feedback (MED_W_10.10, See '5A Book' in this training). - Answers (MED_W_10.10, See '5A Book' in
this training).
Risk Based Approach - Answers In this case it may be considered if the following options can allow
release despite formal errors or gaps.
1. Additional surveillance
2. Conditions on certification
3. Issue certificate with limitation of use
