ISO 13485 2016 Takardar shaidar MDSAP

ISO 13485 2016 Takardar shaidar MDSAP
ISO 13485 2016 Takardar shaidar MDSAP
 

Takardar shaidar yin rajista

TEKNA Manufacturing Pvt. Ltd.

C-19, Masana'antu, Guindy Chennai, Tamil Nadu 600032 INDIA

UL Medical Regulatory Services na UL LLC® (UL) sun ba da wannan takardar shaidar ga Kamfanin da aka ambata a sama, bayan bin diddigin tsarin kula da ingancin kamfanin da gano shi cikin daidaituwa ta ƙayyadaddun ƙimar dangane da:

ISO 13485: 2016

tare da ƙarin buƙatun ƙa'idodi da aka jera a shafi na ƙarshe na wannan takardar shaidar. Zane, ƙira, sabis da girka ɗakunan hyperbaric.

Izini daga

Michael J. Windler, Manajan PE na Sabis na Tsarin Mulki na Distasashen Memba na Ma'aikatan Fasaha UL Life da Kimiyyar Lafiya
UL LLC

Duba Takaddun shaida

Matsayi: a nan

ID ɗin Ginin REPs:

Lambar Takardar Lambar Fayil Ranar Farko

A28843 3017.200413 Afrilu 13, 2020

Kwanan wata Da Farawa Daga Kwanan wata Wanda Ya Zama Ranar Exparewa

Afrilu 13, 2020 Afrilu 13, 2020 Afrilu 12, 2023

Wannan rajistar tsarin ingancin an haɗa ta a cikin Littafin UL na Kamfanoni Masu Rijista kuma ya shafi samar da kayayyaki da / ko ayyuka kamar yadda aka ƙayyade a cikin yankin rajista daga adireshin (im) da aka nuna a sama. Ta hanyar bayar da wannan takardar shaidar kamfanin ya wakilci cewa zai kula da rajistar sa daidai da buƙatun da ake buƙata. Ba a iya canja wurin wannan takardar shaidar kuma ya kasance mallakar UL Medical da Regulatory Services na UL LLC.

Ana iya tabbatar da takaddun shaida ta ziyartar Takaddun Shafin Lantarki akan UL.com.

00-MB-F0867 Fitowa ta 1.0 Shafi 1 na 2

UL Medical and Regulatory Services UL, LLC kungiya ce ta MDSAP wacce aka Gane ta Auditing

UL LLC 333 Pfingsten Road Northbrook, IL 60062-2096 Amurka

UL da tambarin UL alamun kasuwanci ne na Labarun Laboratories Inc. © 2011.

 

Takardar shaidar yin rajista

TEKNA Manufacturing Pvt. Ltd.

C-19, Masana'antu, Guindy Chennai, Tamil Nadu 600032 INDIA

Arin Bukatun Dokoki

ID ɗin Ginin REPs:

Australia:
- Kayayyakin Magunguna (Na'urorin Kiɗa) Dokokin, 2002, Jadawalin 3 Sashe na 1 (ban da Sashi na 1.6) - Tsarin Cikakken Ingantaccen Inganci

Brazil:
- RDC ANVISA n. 16/2013 - RDC ANVISA n. 23/2012 - RDC ANVISA n. 67/2009

Canada:
- Dokokin Kayan aikin Likita - Sashe na 1 - SOR 98/282

Japan:
- Dokar Minista ta MHLW 169, Mataki na 4 zuwa Mataki na 68 - Dokar PMD (, kamar yadda ya dace)

Amurka:

  • - 21 CFR 820

  • - 21 CFR 803

  • - 21 CFR 806

    - 21 CFR 807 - pananan sassa A zuwa D

- 21 CFR 821 (inda ya dace)

Lambar Takardar Lambar Fayil Ranar Farko

A28843 3017.200413 Afrilu 13, 2020

Kwanan wata Da Farawa Daga Kwanan wata Wanda Ya Zama Ranar Exparewa

Afrilu 13, 2020 Afrilu 13, 2020 Afrilu 12, 2023

Wannan rajistar tsarin ingancin an haɗa ta a cikin Littafin UL na Kamfanoni Masu Rijista kuma ya shafi samar da kayayyaki da / ko ayyuka kamar yadda aka ƙayyade a cikin yankin rajista daga adireshin (im) da aka nuna a sama. Ta hanyar bayar da wannan takardar shaidar kamfanin ya wakilci cewa zai kula da rajistar sa daidai da buƙatun da ake buƙata. Ba a iya canja wurin wannan takardar shaidar kuma ya kasance mallakar UL Medical da Regulatory Services na UL LLC.

Ana iya tabbatar da takaddun shaida ta ziyartar Takaddun Shafin Lantarki akan UL.com.

00-MB-F0867 Fitowa ta 1.0 Shafi 2 na 2

UL Medical and Regulatory Services UL, LLC kungiya ce ta MDSAP wacce aka Gane ta Auditing

UL LLC 333 Pfingsten Road Northbrook, IL 60062-2096 Amurka

UL da tambarin UL alamun kasuwanci ne na Labarun Laboratories Inc. © 2011.

Ana buƙatar taimako don zaɓar Ɗaukaka Mafi Tsarki?