Vastuskiri

Dokumendiregister Terviseamet
Viit 11.1-2/24/6105-2
Registreeritud 06.06.2024
Sünkroonitud 10.06.2024
Liik Väljaminev dokument
Funktsioon 11.1 Turustamise järgne järelevalve (post-marketing surveillance)
Sari 11.1-2 Kirjavahetus Eesti turule lastavatest/kasutusele võetavatest/levitatavatest seadmetest MSA kaudu teavitamiseks
Toimik 11.1-2/2023
Juurdepääsupiirang Avalik
Juurdepääsupiirang
Adressaat Synopsys
Saabumis/saatmisviis Synopsys
Vastutaja Karl Kalev Türk (TA, Peadirektori asetäitja (1) vastutusvaldkond, Meditsiiniseadmete osakond)
Originaal Ava uues aknas

Failid

Vs_ notification of medical device - simpleware scanip medical.msg
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From: "Meditsiiniseadmed (Medical Devices)" <mso@terviseamet.ee>
Sent: Thu, 02 Mar 2023 14:25:04 +0000
To: Jessica James <Jessica.James@synopsys.com>
Subject: Vs: notification of medical device - simpleware scanip medical

Dear Jessica,

 

Thank you for your enquiry.

 

Unfortunately, the distribution notification can be only done through Estonian Medical Device Database (EMDDB, https://msa.sm.ee/).

 

For actors outside of Estonia we can make an account manually, so it is possible to log into the database with username and password. For creating an account we need a contact person’s full name, e-mail and the position in the company. Therefore, does the account go to your name?

 

Documents with the notifications of medical devices are following: Declaration of conformity, EC certificate, instruction for use in English, instruction for use in Estonian and copy of the labelling or packaging.

 

Also, please use a short guide for using the Estonian Medical Device Database that can be found on database homepage under „Forms“.

 

NB! Please note that the access to the database is limited to users outside of Estonia.

In case of this, please contact with abi@tehik.ee with an request to access to the database and your IP address. They will white-list your IP and you should have an access to the database.

 

This is a temporary restriction for security reasons which hopefully will be removed in near future.

 

Please do not hesitate to contact me for further information or any questions.

 

Best regards,

 

Karl Kalev Türk

Chief Specialist

Department of Medical Devices

Phone +372 5648 5663

karl.kalev.turk@terviseamet.ee | mso@terviseamet.ee 

 

Republic of Estonia

Terviseamet | Health Board

+372 794 3500

info@terviseamet.ee
www.terviseamet.ee

Paldiski mnt 81, 10614 Tallinn

Estonia

This e-mail is confidential and meant for use by the person named in the letterhead. Any use in any way or copying of it by a person not marked as the addressee thereof is prohibited. If you have got this e-mail by mistake, please notify of it the sender without delay and delete the received e-mail together with all its attachments.

 

Saatja: Jessica James <Jessica.James@synopsys.com>
Saatmisaeg: esmaspäev, 27. veebruar 2023 12:57
Adressaat: Meditsiiniseadmed (Medical Devices) <mso@terviseamet.ee>
Teema: notification of medical device - simpleware scanip medical

 

Tähelepanu! Tegemist on väljastpoolt asutust saabunud kirjaga. Tundmatu saatja korral palume linke ja faile mitte avada.


 

Dear team,

 

Please find below information for registering the non-Estonian manufacturer Synopsys (Northern Europe) Ltd. and the software-only product Simpleware ScanIP Medical for the Estonian market:

 

Name and address of person responsible for placing a product on the Estonian market, responsible for distribution or put into service in Estonia:

 

Synopsys (Northern Europe) Ltd.

Bradninch Hall, Castle Street, Exeter, Devon, EX4 3PL, United Kingdom

simpleware@synopsys.com

+44 (0)1392 428750

 

Contact: Jessica James, simpleware-qms@synopsys.com

 

The name and address of manufacturer of medical devices and, if applicable the name and address of authorised representative in the EU;

 

Manufacturer:

Synopsys (Northern Europe) Ltd.

Bradninch Hall, Castle Street, Exeter, Devon, EX4 3PL, United Kingdom

simpleware@synopsys.com

+44 (0)1392 428750

 

Authorised representative:

Synopsys International Ltd.

Blanchardstown Corp Park, Block 1, Dublin 15, Ireland

simpleware-ce@synopsys.com

353-1-436-8800

 

Name and intended purpose of the device in Estonian and English:

 

Simpleware ScanIP Medical

 

Simpleware ScanIP Medical is intended for use as a software interface and image segmentation system for the transfer of imaging information from a medical scanner such as a CT scanner or an MRI scanner to an output file. It is also intended as pre-operative software for simulating/evaluating surgical treatment options. Simpleware ScanIP Medical is not intended to be used for mammography imaging.

 

Simpleware ScanIP Medical on ette nähtud kasutamiseks tarkvaraliidesena ja pildisegmentimise süsteemina kujutisandmete

ülekandmisel meditsiinilisest skannerist, nagu kompuutertomograafist või magnetresonantstomograafist, väljundfaili. See on ette

nähtud kasutamiseks ka tarkvarana kirurgiliste ravivõimaluste simuleerimisel/hindamisel enne operatsiooni. Simpleware ScanIP

Medical pole ette nähtud kasutamiseks mammograafias

 

https://www.synopsys.com/content/dam/synopsys/simpleware/pdfs/simpleware-scanip-ifu-2022-03_estonian.pdf

 

Identification of the device (commercial name of the device, model or catalogue number):

 

Simpleware ScanIP Medical

 

Software-only device, covering versions:

 

O-2018.12

P-2019.09

Q-2020.03

Q-2020.06

R-2020.09

R-2021.03

S-2021.06

T-2022.03

 

Please let me know if any of this information is unclear, or if any more information is needed.

 

Best,

 

Jessica

 

Jessica James, PhD
Quality Management Representative, Simpleware Software​
w +44 (0)1392 428752 | simpleware-qms@synopsys.com

www.synopsys.com | Bradninch Hall, Castle Street, Exeter, EX4 3PL, UK

 

 

Seosed

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