MDSAP Pre Assessment Questionnaire

MDSAP Pre Assessment Questionnaire

Please complete all 5 sections.

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 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?

YesNo
Does your organization's device(s) incorporate animal material or derivatives?

YesNo
Does your organization's device(s) incorporate medicinal products or pharmaceuticals?

YesNo
Does your organization undertake any operations within a controlled environment or clean-room?

YesNo
Does your organization supply devices in a sterile-condition?

YesNo
What types of sterilization?
Does your organization use a sterilization supplier?

YesNo
Has your organization ever been audited by any Auditing Organization for MDSAP?

YesNo
Previous Auditing Organization(s)
Date of most recent Initial or Recertification Audit

MonthDay Year
Date

Audit history upload

function SvgDhtupload(props) { return /* @__PURE__ */ react.createElement("svg", dhtupload_svg_extends({ width: 54, height: 47, xmlns: "http://www.w3.org/2000/svg" }, props), dhtupload_svg_path || (dhtupload_svg_path = /* @__PURE__ */ react.createElement("path", { d: "M40.213 10.172c1.897.21 3.68.738 5.35 1.58a15.748 15.748 0 014.374 3.242 15.065 15.065 0 012.951 4.533c.72 1.704 1.08 3.522 1.08 5.455 0 1.827-.28 3.654-.843 5.48-.562 1.828-1.379 3.47-2.45 4.929A13.39 13.39 0 0146.669 39c-1.599.948-3.452 1.458-5.56 1.528H37.26a1.62 1.62 0 01-1.185-.5 1.62 1.62 0 01-.501-1.186c0-.457.167-.852.5-1.186.334-.334.73-.5 1.186-.5h3.848c1.44 0 2.75-.37 3.926-1.108a10.851 10.851 0 003.03-2.846 13.53 13.53 0 001.95-3.9 14.23 14.23 0 00.686-4.321c0-1.582-.316-3.066-.949-4.454a11.623 11.623 0 00-2.582-3.636 12.857 12.857 0 00-3.742-2.478 11.054 11.054 0 00-4.48-.922l-1.212-.053-.37-1.159c-.878-2.81-2.292-4.998-4.242-6.562-1.95-1.563-4.594-2.345-7.932-2.345-2.108 0-4.005.36-5.692 1.08-1.686.72-3.136 1.722-4.348 3.005-1.212 1.282-2.143 2.81-2.793 4.585-.65 1.774-.975 3.68-.975 5.718h.053l.105 1.581-1.528.264c-1.863.316-3.444 1.317-4.744 3.004-1.3 1.686-1.95 3.584-1.95 5.692 0 2.39.8 4.462 2.398 6.219 1.599 1.757 3.488 2.635 5.666 2.635h4.849c.492 0 .896.167 1.212.5.316.335.474.73.474 1.187 0 .456-.158.852-.474 1.185-.316.334-.72.501-1.212.501h-4.849a10.08 10.08 0 01-4.374-.975 11.673 11.673 0 01-3.61-2.661 13.173 13.173 0 01-2.478-3.9A12.073 12.073 0 010 28.301c0-2.706.755-5.148 2.266-7.326 1.511-2.178 3.444-3.636 5.798-4.374.14-2.354.658-4.542 1.554-6.562.896-2.02 2.091-3.777 3.584-5.27 1.494-1.494 3.25-2.662 5.27-3.505C20.493.422 22.733 0 25.193 0c1.898 0 3.637.237 5.218.711 1.581.475 3.004 1.151 4.269 2.03a13.518 13.518 0 013.268 3.215 18.628 18.628 0 012.266 4.216zm-11.964 13.44l6.22 6.85c.245.247.368.537.368.87 0 .334-.123.642-.369.923l-.421.263c-.211.246-.484.343-.817.29a1.544 1.544 0 01-.87-.448l-3.69-4.11v16.97c0 .492-.166.896-.5 1.212-.334.316-.729.474-1.186.474-.492 0-.896-.158-1.212-.474-.316-.316-.474-.72-.474-1.212V28.25l-3.584 4.005a1.544 1.544 0 01-.87.448.959.959 0 01-.87-.29l-.42-.264c-.247-.28-.37-.588-.37-.922 0-.334.123-.624.37-.87l6.113-6.746v-.052l.421-.422a.804.804 0 01.396-.29c.158-.053.307-.079.448-.079.175 0 .333.026.474.079.14.053.281.15.422.29l.421.422v.052z", fill: "none" }))); }

Please submit the most recent certification audit report with the nonconformity grade exchange form along with any surveillance reports with nonconformity reports.
Cancelof
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?

YesNo

	Total NCs Raised
Grade 1
Grade 2
Grade 3
Grade 4
Grade 5

Audit Criteria
Audit Criteria
Select MDSAP jurisdictions to include in the scope of your mock audit.

Australia - TG (MD) R & TG ActJapan - MHLW MO169 & PMD ActBrazil - RDC ANVISAUSA - 21 CFRCanada - 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 developmentManufacture of finished devicesInstallationServiceSales / 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
Manufacturing (finished device(s))
Manufacturing (components)
Manufacturing process (except sterilization)
Assembly
Packaging / labelling
Sterilization
Installation
Servicing
Import / Distribution of other manufacturer's devices
Repackaging / relabelling
Refurbishing

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
Should be Empty:

MDSAP Pre Assessment Questionnaire

General Information

Audit Criteria

Scope of mock audit for MDSAP

Audit duration information

Product information