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Ts (Instruments, Test Strips, Reagents), Pharmaceutical Ingredients and Pharmaceuticals Parenteral Production location: Sandhofer Stra e 116 * D-68305 Mannheim (further locations see annex) has successfully implemented the above mentioned environmental management system according to the standard and applies it effectively. The conformity was inspected during the certification audit documented in audit report no. A11051483. This certificate is only valid in connection with the successful perfor.

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The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2020 employed more than 100,000 people worldwide. In 2020, Roche invested CHF 12.2 billion in R&D and posted sales of CHF 58.3 billion. Genentech, in the United States, is a wholly owned member of the Roche Group.

About The Company Roche is the world's largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system.

Commercializing in vitro diagnostic (IVD) devices in the European Union (EU) requires CE marking demonstrating compliance with the IVD regulations. The CE marking indicates that the legal manufacturer has assessed the device and it meets the General Safety and Performance Requirements under the IVDR 2017/746.

Three values sustain our culture and further our quest to help people achieve good health and longevity: integrity, courage and passion. We aspire to embody these values in everything we do.

This “EU Quality Management System Certificate (IVDR)” is mandatory for any manufacturer of in vitro diagnostic devices (IVDs) to issue declarations of conformity for their products and to get them (re-)certified in compliance with the new regulation.

Roche Group | 2022 Global 500 | Fortune.

Roche is the world's largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management.

Roche Diagnostics is headquartered in Rotkreuz, Switzerland.

Our core business is the discovery, development and manufacturing of in vitro tests for the diagnosis of various diseases that include cancer, diabetes, Covid-19, hepatitis, human papillomavirus and many others.

Roché has been certified by QMS International to ISO 9001. This means we have demonstrated our ability to meet customer and regulatory requirements for quality management.

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© Copyright 1997-2025
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Form Packages
Adoption
Bankruptcy
Contractors
Divorce
Home Sales
Employment
Identity Theft
Incorporation
Landlord Tenant
Living Trust
Name Change
Personal Planning
Small Business
Wills & Estates
Packages A-Z
Form Categories
Affidavits
Bankruptcy
Bill of Sale
Corporate - LLC
Divorce
Employment
Identity Theft
Internet Technology
Landlord Tenant
Living Wills
Name Change
Power of Attorney
Real Estate
Small Estates
Wills
All Forms
Forms A-Z
Form Library
Customer Service
Terms of Service
DMCA Policy
About Us
Blog
Affiliates
Contact Us
Privacy Notice
Delete My Account
Site Map
Industries
Forms in Spanish
Localized Forms
State-specific Forms
Forms Kit
Legal Guides
Real Estate Handbook
All Guides
Prepared for You
Notarize
Incorporation services
Our Customers
For Consumers
For Small Business
For Attorneys
Our Sites
US Legal Forms
USLegal
FormsPass
pdfFiller
signNow
airSlate workflows
DocHub
Instapage
Social Media
Call us now toll free:
1-877-389-0141
As seen in:
  • USA Today logo picture
  • CBC News logo picture
  • LA Times logo picture
  • The Washington Post logo picture
  • AP logo picture
  • Forbes logo picture
© Copyright 1997-2025
airSlate Legal Forms, Inc.
3720 Flowood Dr, Flowood, Mississippi 39232