Product Certificate (Medical Devices)

Certification of medical products – our competence:

Within the scope of medical products covered by the following directives implemented into the Polish law:

Medical products:

- Council Directive of 14^th June 1993 on medical devices (93/42/EEC) with amendments

IVD medical devices:

- European Parliament and Council Directive of 27th October 1998 on medical devices for in vitro diagnosis (98/79/EEC) with amendments

Active implantable medical devices:

- Council Directive of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices (90/385/EEC).

WECERT and PCBC are offical partner of National Medical Device Directorate IR. IRAN (IMED) :

in 2018 based on a mutual agreement WECERT and PCBC has been approved by National Medical Device Directorate IR.IRAN (IMED) official partner for issuing ISO 13485:2016 and Medical Device CE Marking.

The scope of Accreditation is according to the following link in IMED Website

Certification Programme

As part of our activities, we certify medical devices based on the following attachments and accreditation area

Directive 93/42/EEC:
• Annex 2 – Full quality assurance system (module H)
• Annex 3 – Type examination (module B)
• Annex 4 – Verification (module F)
• Annex 5 – Production quality assurance (module D)
• Annex 6 – Product quality assurance (module E)

Directive 98/79/EC
• Annex 2 – Full quality assurance system (module H).
• Annex 3 – Type examination (module B)
• Annex 4 – Verification (module F)
• Annex 5 – Production quality assurance (module D)

Directive 90/385/EEC
• Annex 3 – EC Declaration of Conformity (Module A)
• Annex 4 – Full quality assurance system (module H)
• Annex 5 – Type examination (module B)
• Annex 6 – Verification (module F)
• Annex 7 – Ensuring production quality (module D)

Contact Person

Kourosh Azarnia
Product Certificate Manager

Get in Touch

@ Copy Right Worldwide Excellence Certificate (WECERT) - Rojhan Jahangostar Sepanta Co.
Mail
LinkedIn
Facebook
Instagram
Certificate Validator

Privacy Policy

Complaint Handing

Medical Device – Quality Management System Occupational Health & Safety Management System (OH&S)

Cookie and Privacy Settings

How we use cookies

We may request cookies to be set on your device. We use cookies to let us know when you visit our websites, how you interact with us, to enrich your user experience, and to customize your relationship with our website.

Click on the different category headings to find out more. You can also change some of your preferences. Note that blocking some types of cookies may impact your experience on our websites and the services we are able to offer.

Essential Website Cookies

These cookies are strictly necessary to provide you with services available through our website and to use some of its features.

Because these cookies are strictly necessary to deliver the website, refuseing them will have impact how our site functions. You always can block or delete cookies by changing your browser settings and force blocking all cookies on this website. But this will always prompt you to accept/refuse cookies when revisiting our site.

We fully respect if you want to refuse cookies but to avoid asking you again and again kindly allow us to store a cookie for that. You are free to opt out any time or opt in for other cookies to get a better experience. If you refuse cookies we will remove all set cookies in our domain.

We provide you with a list of stored cookies on your computer in our domain so you can check what we stored. Due to security reasons we are not able to show or modify cookies from other domains. You can check these in your browser security settings.

Check to enable permanent hiding of message bar and refuse all cookies if you do not opt in. We need 2 cookies to store this setting. Otherwise you will be prompted again when opening a new browser window or new a tab.

Click to enable/disable essential site cookies.

Google Analytics Cookies

These cookies collect information that is used either in aggregate form to help us understand how our website is being used or how effective our marketing campaigns are, or to help us customize our website and application for you in order to enhance your experience.

If you do not want that we track your visit to our site you can disable tracking in your browser here:

Click to enable/disable Google Analytics tracking.

Other external services

We also use different external services like Google Webfonts, Google Maps, and external Video providers. Since these providers may collect personal data like your IP address we allow you to block them here. Please be aware that this might heavily reduce the functionality and appearance of our site. Changes will take effect once you reload the page.

Google Webfont Settings:

Click to enable/disable Google Webfonts.

Google Map Settings:

Click to enable/disable Google Maps.

Google reCaptcha Settings:

Click to enable/disable Google reCaptcha.

Vimeo and Youtube video embeds:

Click to enable/disable video embeds.

Other cookies

Privacy Policy

Accept settings Hide notification only

× How can I help you?