MDSAP Pre Assessment Questionnaire
Please complete all 5 sections.
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General Information
General Information
Company name (Legal entity)
Note: Name of manufacturer as specified on product labeling
If company is part of a group, please specify
Company Website
Company VAT (TVA) Number
Complete if applicable
Main Address (Certification Address)
Street Address
Street Address Line 2
City
State / Province
Postal / Zip Code
Please Select
United States
Afghanistan
Albania
Algeria
American Samoa
Andorra
Angola
Anguilla
Antigua and Barbuda
Argentina
Armenia
Aruba
Australia
Austria
Azerbaijan
The Bahamas
Bahrain
Bangladesh
Barbados
Belarus
Belgium
Belize
Benin
Bermuda
Bhutan
Bolivia
Bosnia and Herzegovina
Botswana
Brazil
Brunei
Bulgaria
Burkina Faso
Burundi
Cambodia
Cameroon
Canada
Cape Verde
Cayman Islands
Central African Republic
Chad
Chile
China
Christmas Island
Cocos (Keeling) Islands
Colombia
Comoros
Congo
Cook Islands
Costa Rica
Cote d'Ivoire
Croatia
Cuba
Curaçao
Cyprus
Czech Republic
Democratic Republic of the Congo
Denmark
Djibouti
Dominica
Dominican Republic
Ecuador
Egypt
El Salvador
Equatorial Guinea
Eritrea
Estonia
Ethiopia
Falkland Islands
Faroe Islands
Fiji
Finland
France
French Polynesia
Gabon
The Gambia
Georgia
Germany
Ghana
Gibraltar
Greece
Greenland
Grenada
Guadeloupe
Guam
Guatemala
Guernsey
Guinea
Guinea-Bissau
Guyana
Haiti
Honduras
Hong Kong
Hungary
Iceland
India
Indonesia
Iran
Iraq
Ireland
Israel
Italy
Jamaica
Japan
Jersey
Jordan
Kazakhstan
Kenya
Kiribati
North Korea
South Korea
Kosovo
Kuwait
Kyrgyzstan
Laos
Latvia
Lebanon
Lesotho
Liberia
Libya
Liechtenstein
Lithuania
Luxembourg
Macau
Macedonia
Madagascar
Malawi
Malaysia
Maldives
Mali
Malta
Marshall Islands
Martinique
Mauritania
Mauritius
Mayotte
Mexico
Micronesia
Moldova
Monaco
Mongolia
Montenegro
Montserrat
Morocco
Mozambique
Myanmar
Nagorno-Karabakh
Namibia
Nauru
Nepal
Netherlands
Netherlands Antilles
New Caledonia
New Zealand
Nicaragua
Niger
Nigeria
Niue
Norfolk Island
Turkish Republic of Northern Cyprus
Northern Mariana
Norway
Oman
Pakistan
Palau
Palestine
Panama
Papua New Guinea
Paraguay
Peru
Philippines
Pitcairn Islands
Poland
Portugal
Puerto Rico
Qatar
Republic of the Congo
Romania
Russia
Rwanda
Saint Barthelemy
Saint Helena
Saint Kitts and Nevis
Saint Lucia
Saint Martin
Saint Pierre and Miquelon
Saint Vincent and the Grenadines
Samoa
San Marino
Sao Tome and Principe
Saudi Arabia
Senegal
Serbia
Seychelles
Sierra Leone
Singapore
Slovakia
Slovenia
Solomon Islands
Somalia
Somaliland
South Africa
South Ossetia
South Sudan
Spain
Sri Lanka
Sudan
Suriname
Svalbard
eSwatini
Sweden
Switzerland
Syria
Taiwan
Tajikistan
Tanzania
Thailand
Timor-Leste
Togo
Tokelau
Tonga
Transnistria Pridnestrovie
Trinidad and Tobago
Tristan da Cunha
Tunisia
Turkey
Turkmenistan
Turks and Caicos Islands
Tuvalu
Uganda
Ukraine
United Arab Emirates
United Kingdom
Uruguay
Uzbekistan
Vanuatu
Vatican City
Venezuela
Vietnam
British Virgin Islands
Isle of Man
US Virgin Islands
Wallis and Futuna
Western Sahara
Yemen
Zambia
Zimbabwe
Other
Country
Person completing questionnaire
First Name
Last Name
Email
example@example.com
Primary Contact Person
First Name
Last Name
Email
example@example.com
Title
Phone Number
Please enter a valid phone number.
Secondary Contact Person
First Name
Last Name
Email
example@example.com
Title
Phone Number
Please enter a valid phone number.
Total Number of employees in organization (all-sites)
This includes all sites and all employees working on-site or at a remote location
In what language are your quality system procedures?
Does your organization design software (standalone or embedded) that is used to control your devices?
Yes
No
Does your organization's device(s) incorporate animal material or derivatives?
Yes
No
Does your organization's device(s) incorporate medicinal products or pharmaceuticals?
Yes
No
Does your organization undertake any operations within a controlled environment or clean-room?
Yes
No
Does your organization supply devices in a sterile-condition?
Yes
No
What types of sterilization?
Does your organization use a sterilization supplier?
Yes
No
Has your organization ever been audited by any Auditing Organization for MDSAP?
Yes
No
Previous Auditing Organization(s)
Date of most recent Initial or Recertification Audit
-
Month
-
Day
Year
Date
Number of NCs Raised
Total NCs Raised
Grade 1
Grade 2
Grade 3
Grade 4
Grade 5
Audit history upload
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Please submit the most recent certification audit report with the nonconformity grade exchange form along with any surveillance reports with nonconformity reports.
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Consultancy services
If you have used or intend to use consultancy services for your quality management system, please provide details
Number of sites
How many sites will be reviewed by the mock audit? This is the same number as you will need covered by actual certification
Are all sites under the same QMS?
Yes
No
Audit Criteria
Audit Criteria
Select MDSAP jurisdictions to include in the scope of your mock audit.
Australia - TG (MD) R & TG Act
Japan - MHLW MO169 & PMD Act
Brazil - RDC ANVISA
USA - 21 CFR
Canada - Medical Device Regulations (MDR)
For each jurisdiction selected above, provide the license number with the regulatory authority.
Identification Number
If no ID No. available, provide clarifications
Australia
Canada
Japan
Brazil
United States
Provide additional clarification or information if necessary
Scope of mock audit for MDSAP
Scope of mock audit for MDSAP
Activities Performed
Design and development
Manufacture of finished devices
Installation
Service
Sales / Distribution
Device Groups
Optional: additional information regarding range of activities
Activities can include design & development, manufacturing, distribution, service & install etc.
Info needed for audit duration
Audit duration information
Extent of outsourcing
Performed in-house
Outsourced
Design and development
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25%
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Manufacturing (finished device(s))
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Manufacturing (components)
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100%
Manufacturing process (except sterilization)
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Assembly
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Packaging / labelling
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Sterilization
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Installation
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Servicing
0%
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0%
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100%
Import / Distribution of other manufacturer's devices
0%
25%
50%
75%
100%
0%
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50%
75%
100%
Repackaging / relabelling
0%
25%
50%
75%
100%
0%
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100%
Refurbishing
0%
25%
50%
75%
100%
0%
25%
50%
75%
100%
Others?
Provide additional information if necessary to define the extent of outsourcing and in-house activities
Number of shifts
Number of employees per shift
Times of shifts
Description of activities per shift
Off-site activities
If activities are conducted off-site during daytime working hours, provide details
Sterile devices
If your organization performs sterilization processes on-site, please provide details
Additional details
Please provide any additional information if necessary
List of critical suppliers
Product Information
Product information
Product info - Canada
Product info - Brazil
Product info - Japan
Product info - Australia
Product info - USA
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