Submit a Certification Request Form

"*" indicates required fields

Step 1 of 14

This offer request application contains all necessary fields for HTCert to understand the structure of your company. It will take approximately 30 minutes and you will have the option to move forward and backwards.

Billing Details

Legal Entity Name*

Tax Identification Number*

Billing Address*

Street Address Address Line 2 City State / Province / Region ZIP / Postal Code Country

Contact Person

The first contact person will receive all communication

Contact Person*

Position in the company*

Phone*

Contact Person Email*

Extra Contact Persons

Name

Position in the company

Phone

Employee Status

Total number of employees*

(full and part time)

Number of Shifts*

Number of Part-Time employees

Number of employees Performing Same or Similar Repetitive Task*

Please enter a number greater than or equal to 0.

Activities considered for estimation of the number of employees performing same or similar repetitive task shall be of low risk and low complexity (e.g. cleaners, security, transport, sales, call centers, etc)

Other Sites

If the quality management system includes Additional Facilities, please complete the following table. In case there are more than 1 facilities, please make a copy of this table and provide details for all facilities

Additional Facilities

Location

Contact Person

Number of Shifts

Total number of employees (full and part time)

Number of Part-Time Employees

Number of employees Performing Same or Similar Repetitive Task

Subcontractors

If there are more than one subcontractors, please make a copy of this table and provide details for all. Please describe in which way outsourced processes are monitored and controlled (e.g. by auditing of subcontractors, by in-coming inspection, subcontractors are certified to MDD, ISO 13485 or ISO 9001) Please attach copies of any relevant certificates.

Subcontractor's List

Company Name

Address

Devices concerned

Services Provided

Control of Processes

Select or enter an option

to add more services provided, please write the service you want and hit enter

Company activities

Design & Development of

Production of

Distribution of

Installation of

Servicing of

Specify any other activity

if the quality management system includes Additional Facilities, please indicate the activities performed in each location

Design & Development

Main Site

A.F.1

A.F.2

Subcontractor

Purchasing

Main Site

A.F.1

A.F.2

Subcontractor

Manufacturing

Main Site

A.F.1

A.F.2

Subcontractor

Packaging

Main Site

A.F.1

A.F.2

Subcontractor

Sterilization

Main Site

A.F.1

A.F.2

Subcontractor

Product testing

Main Site

A.F.1

A.F.2

Subcontractor

Servicing activities

Main Site

A.F.1

A.F.2

Subcontractor

Customer Service/Sales

Main Site

A.F.1

A.F.2

Subcontractor

Storage & Distribution

Main Site

A.F.1

A.F.2

Subcontractor

Management / Administration

Main Site

A.F.1

A.F.2

Subcontractor

Quality Assurance / Regulatory Affairs

Main Site

A.F.1

A.F.2

Subcontractor

Scope of Certification

Quality Management System

ΕΝ ISO 13485:2016

ΕΝ ISO 9001:2015

Required Certification Scope

Medical Device Directive MDD 93/42/EEC

Annex II excluding (4)

Annex V

Annex II.4

Desired date of the audit

DD slash MM slash YYYY

Is a pre-audit requested?*

Yes

Current Certification Status

Is this a new application or an extension to an existing Certification?

New

Extention of Existing

Is this a transfer from another Notified Body?

Yes

In this case please attach copies of all current certificates

Drop files here or

Max. file size: 256 MB.

Is Certification for another standard held?

Yes

Certification for another standard held List

Certification Body

Certificate No

Standard

External consultants*

Did you receive consultancy services regarding the implementation of the quality management system?

Yes

by:

Quality System Documentation/Structure*

One quality manual/set of procedures covers all facilities

Separate quality manual/procedures for each facility

Other

List and classification of products

List of Products

Product description and intended use

Name of Technical File

MD / MDS code

GMDN Code

Class

Rule

OBL

Sterilized from user before use?

MD0101

YES

Please attach product information (e.g. brochures, IFU, detailed description of the intended use).
MD / MDS code: as in NBOG BPG 2009-3
GMDN: Global Medical Device Nomenclature If not available, please specify UMDNS code (UMDNS: Universal Medical Device Nomenclature System)
OBL: Own Brand Labeller. Tick Yes if the products are being placed on the market as Own Brand Labelled Products, i.e. products which are marketed under your own brand name, but which are completely manufactured by another company. Please attach copies of the existing certificates of the OEM supplier.

Sterilization method

moist heat

ethylene oxide

irradiation

Other sterilization method

Class III devices

Device

Sterile?

Contains medicinal substance?

Is the medicinal substance officially registered for EU?

Contains a human blood derivative?

Contains materials of animal origin?

For Class III devices, please complete additionally the following table, providing as much detail as possible

Authorized EC Representative

(if applicable)

Company Name (Authorized EC Representative)

Contact Person

First Last

Phone no

Fax no

Address

Street Address Address Line 2 City ZIP / Postal Code Country

Website

Attachments

Company brochure*

Drop files here or

Max. file size: 256 MB.

Organization chart of the headquarter*

Drop files here or

Max. file size: 256 MB.

Organization chart of subsidiaries / branches

Drop files here or

Max. file size: 256 MB.

Company’s current certificates

Drop files here or

Max. file size: 256 MB.

Certificates of subcontractors

Drop files here or

Max. file size: 256 MB.

Detailed product documentation

Drop files here or

Max. file size: 256 MB.

Finalize

Submitted by*

enter your name as signature

Position in the company*

Privacy*

I agree to the Privacy Policy.

I agree to the Terms of Use

Hidden

Decisions (2)

Certification for

Codes

Starting Date

Expiration Date

Scope

Status

Transfer

Date of Issuance of Initial Certificate

DD slash MM slash YYYY

Certification Files

Drop files here or

Max. file size: 256 MB.

This field is for validation purposes and should be left unchanged.

Company Information

Billing Details

Contact Person

Employee Status

Other Sites

Subcontractors

Company activities

Scope of Certification

Current Certification Status

List and classification of products

Authorized EC Representative

Attachments

Finalize