Page 1 of 11 MDF7300 Issue 1 Company Information Form Medical Devices Continue Let BSI help you meet the world with confidence. Our mission is to ensure patient safety while supporting timely access to global medical device technology. We strive to set the global standard in thorough, responsive, predictable conformity assessments, evaluations, and certifications. In order to start our quotation process we need certain information. For this purpose, we kindly request you to fill out the questionnaire below. (This form can be completed and submitted using Adobe Acrobat Reader, alternatively please print clearly). Company Information Form Section A: Company Information. Legal Company Name: Address: Country: Website: Regulatory Correspondent: Primary contact: Secondary contact: Name: Name: Position: Position: Tel: Tel: Fax: Fax: Mobile: Mobile: Email: Email: Is your company part of a larger organization? If so, please give details of the organization: Do you trade under any other trading names? If so, please give further details: Authorised European Representative: (if company not resident in EU) Legal Company Name: Representative Title/Name/Position: Consultants: For the products and services listed within this form, will you be using or have you previously used a Consultant to help you in your design, construction, marketing or maintenance of the products, processes or Quality Management Systems? Yes No (If applicable, please complete their details below) Consultant name: Address: Email: Tel:
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Page 1 of 11 MDF7300 Issue 1
Company Information Form Medical Devices
Continue
Let BSI help you meet the world with confidence. Our mission is to ensure patient safety while supporting timely access to global medical device
technology. We strive to set the global standard in thorough, responsive, predictable conformity assessments, evaluations, and certifications.
In order to start our quotation process we need certain information. For this purpose, we kindly request you to fill out the questionnaire below.
(This form can be completed and submitted using Adobe Acrobat Reader, alternatively please print clearly).
Company Information Form
Section A: Company Information.
Legal Company Name:
Address:
Country: Website:
Regulatory Correspondent:
Primary contact: Secondary contact:
Name: Name:
Position: Position:
Tel: Tel:
Fax: Fax:
Mobile: Mobile:
Email: Email:
Is your company part of a larger organization? If so, please give details of the organization:
Do you trade under any other trading names? If so, please give further details:
Authorised European Representative: (if company not resident in EU)
Legal Company Name:
Representative Title/Name/Position:
Consultants:For the products and services listed within this form, will you be using or have you previously used a Consultant to help you in your design,
construction, marketing or maintenance of the products, processes or Quality Management Systems? Yes No
(If applicable, please complete their details below)
Consultant name:
Address:
Email: Tel:
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Company Information Form Medical Devices
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Section B: Services requested
Please select the services you would like BSI to provide a quotation or provide information? For a description of these services please refer to the
annex at the back of this pdf or ask your sales representative for more information.
Medical Device Related Services:
Initial application Transfer from another Notified Body/Certification Body
CE certification to MDD, AIMD Directive Medical device or quality system related training
ISO 13485:2016 (UKAS) Safety testing (IEC 60601 and/or EMC)
ISO 13485:2016 (RvA) Australia TGA/EU MRA Fast Track Service
(Applicable only to products manufactured in Europe)
ISO 13485:2016 (SCC) Japan PMD Act certification
Malaysia CAB product approval
Medical Device Single Audit Program (MDSAP)
Accelerated Medical Device Registration in
Taiwan (Applicable only to EU Manufacturers)
ISO 9001:2015 (UKAS)
Hong Kong CAB product approval ISO 9001:2015 (ANAB)
Saudi Arabia CAB services (Information only)
CE Marking Technical Documentation Review Services:
Please select which technical documentation review service you would like to receive a quotation for?
CE-Standard
CE-Dedicated FastTrack
CE-Onsite FastTrack
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Company Information Form Medical Devices
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Section C: Information required for quality system assessmentPlease complete this section if you are applying for ISO 13485/9001 and CE certification. In case of CE marking, please also complete section D (product information).
Company Organization:
If the company consists of several locations all contributing to the overall scope of any proposed application then please complete this section. Please
clearly indicate where design, manufacturing, sterilization etc take place. Use an additional sheet if necessary.
Site Details: Main Site
Name:
Address:
Functions/Activities:
Number of employees: Shift system (hours/number of shifts/number of employees per shift):
Site Details: Second Site
Name:
Address:
Functions/Activities:
Number of employees: Shift system (hours/number of shifts/number of employees per shift):
Site Details: Third Site
Name:
Address:
Functions/Activities:
Number of employees: Shift system (hours/number of shifts/number of employees per shift):
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Company Information Form Medical Devices
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Existing Certificate Details:
Please provide copies of any CE marking or ISO 13485 certificates held.
Main Site Second Site Third Site
Certificate Number:
Certificate Type:
Issuer of Certificate:
Current Certification Scope:
Materials:
Please indicate the material base of your products: Plastic Metal Organic Other
New Applications:
Suggested scope of certification of your quality system:
Client Readiness:
When will your QMS be ready for assessment?
When will your technical documentation be ready for assessment?
Main Site Second Site Third Site
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Company Information Form Medical Devices
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Section D: Information required for CE certification.
Please complete this section if you request a quotation for CE certification.
90/385/EEC – AIMD (Active Implantable Medical Devices)
93/42/EEC – MDD (Medical Devices)
Route to Conformity Which conformity assessment procedure(s) would you like to follow?
MDD or AIMD – Annex II (Full Quality System) MDD – Annex IV (EC Verification) MDD – Annex III (Type/Design Examination)
MDD – Annex V (Production Quality System) MDD – Annex VI (Product Quality System)
Product Details:
Please give details of the devices to be included in the scope of this application. Copies of any product literature should be included.
Device Name Device Description/ Classification Rule Justification for Is the device Sterilization Sterilization
Intended use Classification sterile? Yes/No Method Location
(please also indicate if in-house or sub- contracted)
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Magnetic Resonance Compatibility:
Is the device specified for use in the MR environment? Yes (MR Safe/MR Conditional) No (MR Unsafe)
Software:
What is the software classification according to EN 62304? A B C
Accessories: If any accessories are included, please give details whether sold with the product or separately:
Special Materials:
Does the device(s) contain any medicinal substances or human blood derivatives? Yes No
If YES, please give details of medicinal substance including name, sourcing, availability of ASMF or CEP, previous consultations held with a
national Competent Authority or EMA. If the substance is considered as non-liable to act on the human body as presented in the device, please provide a
justification for this as a separate document
Does the device(s) contain or utilize any non-viable animal tissues or derivatives? Yes No
If YES, please indicate the tissue/derivative, country of origin (sourcing country) and EDQM certificate details (if applicable)?
Special Processes:
Please give details of any special processes carried out e.g. Sterilization:
Please indicate brand/method of sterilization:
Has/have the sterilization validation(s) been completed? Yes No
If No, please indicate the expected date of completion:
Has/have the shelf life and expiry dating validation(s) been completed? Yes No
If No, please indicate the expected date of completion:
Is the device intended for sterilization by the end user? Yes No
Are the instructions for sterilization and cleaning included in the IFU? Yes No
Have the instructions for sterilization and cleaning been validated to support the IFU? Yes No
Novelty:
Is the device a new development to the market? Yes No
Does the device feature any novel features such as materials, technologies or intended use?
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Sub-contractors:
Are any processes sub-contracted, e.g. design, manufacturing, sterilization, cleaning, packaging, servicing, vigilance, post market surveillance, QC Testing?
If so, please specify activity, to whom they are sub-contracted and details of any quality systems held by the sub-contractor.
Contact: Sub-contractor 1
Name:
Address:
Activity Sub-contracted:
Existing Registrations?
Please confirm whether you have provided copies of certificates: Yes No
Contact: Sub-contractor 2
Name:
Address:
Activity Sub-contracted:
Existing Registrations?
Please confirm whether you have provided copies of certificates: Yes No
Contact: Sub-contractor 3
Name:
Address:
Activity Sub-contracted:
Existing Registrations?
Please confirm whether you have provided copies of certificates: Yes No
Additional Information:Please use this area to provide any additional information including audit language requirements which you think would be helpful in progressing
the quotation process:
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Company Information Form Medical Devices
Please return this form to BSI with a copy of your standard company information, the product brochures and any other information which you
think would be helpful in the quotation process.
Declaration:The applicant herewith declares to have lodged no application with any other Notified Body for the same device-related quality management
system.
The applicant herewith declares to have lodged no application with any other Notified Body for the same device(s).
The applicant herewith confirms that the information provided in this application is true and correct.