• Home
  • About Us
    • About Requalite
    • Our Values
    • Our Team
  • Services
    • Regulatory Consulting
    • Quality Management Consulting
    • Performance Evaluation Report
    • Clinical Evaluation Report
    • Literature Search Report
    • Post-market Surveillance Report
    • Periodic Safety Update Report (PSUR)
    • EU Authorised Representative (EC REP)
    • Gap Analysis
    • Training
  • Resources
    • EU Regulation 2017/746 (IVDR)
    • EU Regulation 2017/745 (MDR)
    • ISO 13485 QMS for Medical Devices
    • ISO 14971 Risk Management
    • White papers
    • Presentations
  • Links
    • Guidelines
    • Regulations
  • News
  • FAQ
  • Contact
  • en English
    en Englishde German
MDCG Questions and Answers on Custom-Made Devices is released

MDCG Questions and Answers on Custom-Made Devices is released

by inanconsulting | Mar 16, 2021 | Uncategorized

EU Medical Device Coordination Group (MDCG) has endorsed and released a new document addressing pertinent questions in regards to Custom-made devices under MDR 2017...
New CER Template is released!

New CER Template is released!

by inanconsulting | Mar 11, 2021 | Uncategorized

MDCG has released a new guidelines for CER template as per MDR...
4th Notified Body under IVDR announced !

4th Notified Body under IVDR announced !

by inanconsulting | Mar 11, 2021 | Uncategorized

EU has announced that TUV Rheinland is accredited as the 4th Notified Body under...
  • Home
  • About Us
    • About Requalite
    • Our Values
    • Our Team
  • Services
    • Regulatory Consulting
    • Quality Management Consulting
    • Performance Evaluation Report
    • Clinical Evaluation Report
    • Literature Search Report
    • Post-market Surveillance Report
    • Periodic Safety Update Report (PSUR)
    • EU Authorised Representative (EC REP)
    • Gap Analysis
    • Training
  • Resources
    • EU Regulation 2017/746 (IVDR)
    • EU Regulation 2017/745 (MDR)
    • ISO 13485 QMS for Medical Devices
    • ISO 14971 Risk Management
    • White papers
    • Presentations
  • Links
    • Guidelines
    • Regulations
  • News
  • FAQ
  • Contact
  • en English
    en Englishde German

Address

Requalite GmbH
Jahnplatz 4, 82166 Gräfelfing

 

Contact Us

☎  +(49)-89-328 00 304

✉    info@requalite.com

 

  • Follow
  • Follow
  • Follow

Requalite is a medical device Regulatory and Quality Consulting company located at the heart of Europe, in Munich-Germany. We provide full technical and medical writing support to manufacturers of Medical Device and In vitro Diagnostic devices to obtain CE-marking as per EU regulations of MDR (2017/745) and IVDR (2017/746) for entering European market.

Impressum 

Copyright © 2021 Requalite

We use cookies on our website to give you the most relevant experience by remembering your preferences and repeat visits. By clicking “Accept All”, you consent to the use of ALL the cookies. However, you may visit "Cookie Settings" to provide a controlled consent.
Cookie SettingsAccept All
Manage consent

Privacy Overview

This website uses cookies to improve your experience while you navigate through the website. Out of these, the cookies that are categorized as necessary are stored on your browser as they are essential for the working of basic functionalities of the website. We also use third-party cookies that help us analyze and understand how you use this website. These cookies will be stored in your browser only with your consent. You also have the option to opt-out of these cookies. But opting out of some of these cookies may affect your browsing experience.
Necessary
Always Enabled
Necessary cookies are absolutely essential for the website to function properly. This category only includes cookies that ensures basic functionalities and security features of the website. These cookies do not store any personal information.
Non-necessary
Any cookies that may not be particularly necessary for the website to function and is used specifically to collect user personal data via analytics, ads, other embedded contents are termed as non-necessary cookies. It is mandatory to procure user consent prior to running these cookies on your website.
SAVE & ACCEPT
 

Loading Comments...