This is to certify that Medical devices.Quality'management systems. Requirements for-regulatory purposes according to Appendix No. 1 to this certificate (the attachment is an integral part of the certificate) . CERTIFICATION SYSTEM f l FEDERAL AGENCY ON TECHNICAL REGULATING AND METROLOGY < z V. ! is issued to VOLUNTARY CERTIFICATION SYSTEM "SMK STANDART" " Reg. No. РОСС RU.31060.04ЖЖЮ0 Certification authority: REGNo. SMK STANDART.RU.0005 INTERNATIONAL CERTIFICATION CENTER Limited Liability Company Address: 112/2, Lit. “I”, Obukhovskoy Oborony Prospect, Office 514. St. Petersburg, 192012 Phone: +7 (812) 409-42-02; E-mail: [email protected]_ Check the authenticity of the certificate in the register on the website http://www.iso-smk.ru ... „Хм . ' 77 - •. X -J ' L CERTIFICATE OF CONFORMITY No. ST.RU.0001.M0020529 I I i Scientific and Research Centre MATRIX, Limited Liability Company Address: 26. Gruzinskiy Vai St., Building 3, Office 1, Moscow, 123056 Place of manufacture: 29, Sokolovo-Meshcherskaya St., Moscow, 125466 TIN 7710522847 OGRN 1037789071066 COMPLY WITH THE REQUIREMENTS OF GOST ISO 13485-2017 (ISO 13485:2016) ■= /■ ■ Expert XXn f vy у. L XX XXa7 / ) THIS CERTIFICATE BINDS THE ORGANIZATION TO MAINTAIN THE WORKS PERFORMED. ACCORDINtft’O THE^BOVE MENTIONED STANDARD, TO $E ' ~ -GONTROLLEELBY THE INSTITUTIONAL BODY OF VOLUNTARY^CERTIFICATION X . ' ' ' SYSTEM-“SMK STAip'ART’ AND IS CONFIRMED DURING THE ANNUAL INSPECTION CONTROL/ - Manager of Certification authority A.M; Sotnikov ________O.V. Gundareva ! ~ ' / ■ - - A •' Z
Transcript
This is to certify thatMedical devices.Quality'management systems. Requirements for-regulatory purposes
according to Appendix No. 1 to this certificate (the attachment is an integral part of the certificate)
. CERTIFICATION SYSTEM f lFEDERAL AGENCY ON TECHNICAL REGULATING AND METROLOGY
INTERNATIONAL CERTIFICATION CENTER Limited Liability Company Address: 112/2, Lit. “I”, Obukhovskoy Oborony Prospect, Office 514. St. Petersburg, 192012
Phone: +7 (812) 409-42-02; E-mail: [email protected] _Check the authenticity of the certificate in the register on the website http://www.iso-smk.ru
... „Хм . ' 77 - •.X -J 'L
CERTIFICATE OF CONFORMITYNo. ST.RU.0001.M0020529
IIi
Scientific and Research Centre MATRIX, Limited Liability CompanyAddress: 26. Gruzinskiy Vai St., Building 3, Office 1, Moscow, 123056
Place of manufacture: 29, Sokolovo-Meshcherskaya St., Moscow, 125466TIN 7710522847 OGRN 1037789071066
COMPLY WITH THE REQUIREMENTS OF GOST ISO 13485-2017 (ISO 13485:2016) ■= /■ ■
Expert
XXn f vyу. L XX XXa7 /
) THIS CERTIFICATE BINDS THE ORGANIZATION TO MAINTAIN THE WORKS PERFORMED. ACCORDINtft’O THE^BOVE MENTIONED STANDARD, TO $E' ~ -GONTROLLEELBY THE INSTITUTIONAL BODY OF VOLUNTARY^CERTIFICATION X . ' '
' SYSTEM-“SMK STAip'ART’ AND IS CONFIRMED DURING THE ANNUAL INSPECTION CONTROL/ -
Manager of Certification authority
A.M; Sotnikov ________O.V. Gundareva! ~
' / ■ - - A •' Z
Scope of the quality management system certification
Development and production of laser physical therapy equipment
A.M. Sotnikov
' CERTIFICATION SYSTEMFEDERAL AGENCY ON TECHNICAL REGULATING AND METROLOGY
Scientific and Research Centre MATRIX, Limited Liability CompanyAddress: 26, Gruzinskiy Vai St., Building 3, Office 1, Moscow, 123056
Place of manufacture: 29, Sokolovo-Meshcherskaya St., Moscow, 125466
CERTIFICATION SYSTEMFEDERAL AGENCY ON TECHNICAL REGULATING AND METROLOGY
VOLUNTARY CERTIFICATION SYSTEM "SMK STANDART" j
Reg. No. РОСС КЕт.31060.04ЖЖЮ0
f
LICENSE
1 - T''' J ' ЛвИ
A.M. Sotnikov^®41-'
\ \ J -■Quality management system certification authority
INTERNATIONAL CERTIFICATION CENTER/Limited Liability Company upon a decision to issue the certificate of the quality management systems conformity
TO USE THE CERTIFICATION SYSTEM CONFORMITY MARK "SMK STANDART" !
Certification authority:REG No. SMK STANDART.RU.0005 V
INTERNATIONAL CERTIFICATION CENTER Limited Liability Company Address: 112/2, Lit. “I”, Obukhovskoy Oborony Prospect, Office 514, St. Petersburg, 192012
AUTHORIZES _to use the mark of the quality management system conformity for the validity period of the
Certificate No. STRU.0001 .M0020529’ a':7 ' ■ ■ .
in any form-excluding its reading as a mark of the product quality conformity .The conformity mark is allowed to-be used in the advertising:booklets, leaflets, brochures, form sheets
of the organization directional documentation ofc
& /1ML • s-:; ••• ; *£££•■ ■ I -,
Manager of Certification authority.................... .....
Tatiana Valerievna Moskvina
Experttion authority
A.M. Sotnikov
CERTIFICATION SYSTEMFEDERAL AGENCY ON TECHNICAL REGULATING AND METROLOGY
VOLUNTARY CERTIFICATION SYSTEM "SMK ST AND ART"
Reg. No. РОСС Ии.31060.04ЖЖЮ0
Meets the requirements of the certification management system “SMK STAND ART” related to the auditors, fulfilling quality management system internal checks in conformity with the
following standard:"Medical devices. Quality management systems. Requirements for regulatory purposes"
Meets the requirements of the certification management system “SMK STANDART” related to the auditors, fulfilling quality management system internal checks in conformity with the
following standard:"Medical devices. Quality management systems. Requirements for regulatory purposes"
>// ' - \AUDITOR’S CERTIFICATE OF CONFORMITY
Vitalina Vladimirovna Kiseleva
GOST ISO 13485-2017 (ISO 13485:2016)
A.M. Sotnikov
CERTIFICATION SYSTEMFEDERAL AGENCY ON TECHNICAL REGULATING AND METROLOGY
O.V. Gundare
W / Expert
« ; - У
VOLUNTARY CERTIFICATION SYSTEM "SMK STANDART" .
Reg. No. РОСС 1<1.31060.04ЖЖЮ0
Meets the requirements of the certification management system "SMK STAND ART” related to the auditors, fulfilling quality management system internal checks in conformity with the
following standard:"Medical devices. Quality management systems. Requirements for regulatory purposes"
INTERNATIONAL CERTIFICATION CENTER Limited Liability Company Address: 112/2, Lit. “I”, Obukhovskoy Oborony Prospect, Office 514, St. Petersburg, 192012
AUDITOR’S CERTIFICATE OF CONFORMITYNo. ST.RU.EXP.00020529-3
GOST ISO 13485-2017 (ISO 13485:2016)
A.M, Sotnikov
CERTIFICATION SYSTEM .FEDERAL AGENCY ON TECHNICAL REGULATING AND METROLOGY
O.V. Gundare
ManagerJS\\ Z?Вг/Хг) л- A
VOLUNTARY CERTIFICATION SYSTEM "SMK STAND ART” 2
Reg. No. РОСС Ни.31060.04ЖЖЮ0
Meets the requirements of the certification management system “SMK STAN DART” related to the auditors, fulfilling quality management system internal checks in conformity with the
following standard:"Medical devices-AJuality management systems. Requirements for regulatory purposes"
INTERNATIONAL CERTIFICATION CENTER Limited Liability Company Address: 112/2, Lit. “I”, Obukhovskoy Oborony Prospect, Office 514, St. Petersburg, 192012
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