Service

Valicare GmbH

Postfach 940350 , 60461 Frankfurt
Eschborner Landstr. 130-132 , 60489 Frankfurt
Germany

Telephone +49 69 7909350/442
Fax +49 69 7909345
info@valicare.com

This company is co-exhibitor of
DiagnostikNet-BB Netzwerk Diagnostik Berlin-Brandenburg e.V.

Trade fair hall

  • Hall 3 / G60
 Interactive Plan

Hall map

MEDICA 2016 hall map (Hall 3): stand G60

Fairground map

MEDICA 2016 fairground map: Hall 3

Our range of products

Product categories

  • 07  Medical Services and Publications
  • 07.01  Reports and analyses
  • 07  Medical Services and Publications
  • 07.01  Reports and analyses
  • 07.01.03  Evaluations
  • 07  Medical Services and Publications
  • 07.10  Technical equipment management, Test houses / Certification Bodies

Technical equipment management, Test houses / Certification Bodies

  • 07  Medical Services and Publications
  • 07.10  Technical equipment management, Test houses / Certification Bodies
  • 07.10.02  Certification and testing of medical devices, quality assurance

Certification and testing of medical devices, quality assurance

Our products

Product category: Reports and analyses

GMP Compliance for Medical Devices

GMP for Companion Diagnostics, Combination Products and ATMP
  • GMP Consulting
  • GMP risk management
  • GMP GAP analysis
  • GMP design review
  • Support for and preparation of customer and NB audits
  • Mock audit
  • Third-party audit
  • Change management
  • Supplier qualification
  • Preparation of documentation
  • Training of GMP fundamentals and customer specific subjects

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Product category: Evaluations

Qualification & Validation

  • Validation concept
  • Validation Master Plan
  • Risk based qualification and validation
  • Qualification and validation specific education and training
  • Process validation
  • Preparation of documentation
  • Technical risk management
  • Process, cleaning, and method validation
  • IT validation (hardware qualification / software validation)
  • Documentation of validation status
  • Preparation of comprehensive qualification and validation documentation
  • Annotation, correction, and revision of existing documentation
  • Qualification and validation reviews

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Product category: Technical equipment management, Test houses / Certification Bodies

Technical equipment management

  • Service and maintenance concepts
  • Calibration service
  • Risk classification
  • Technical risk analysis
  • Qualification concept
  • Purchase, consignment, DQ/IQ/OQ/PQ
  • Execution of qualification
  • Inventory
  • Technical and IT risk analysis
  • GAMP Categorisation
  • Final qualification report
  • Re-qualification

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Product category: Certification and testing of medical devices, quality assurance

Regulatory Affairs & Quality Management

Regulatory Affairs Consulting
  • Regulatory due diligence
  • IVD Directive => IVD Regulation
  • MD Directive => MP Regulation
  • Risk management according ISO 14971
  • Process risk management
  • Technical documentation according STED format
  • Design dossier
  • Clinical evaluation
  • Clinical evidence
  • Biocompatibility
  • CE mark
Quality Management according ISO 13485
  • Development and implementation
  • GAP analysis
  • Supplier qualification
  • Supplier audits
  • Internal audits
  • CAPA
  • Training

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About us

Company details

Valicare, an independent subsidiary of Robert Bosch GmbH, Packaging Technology Group, offers GMP consulting and risk based qualification and validation of single equipment, complex manufacturing facilities, and processes within the medical device, biotechnology, and pharmaceutical industry.

Within Regulatory Affairs and Quality Management we support the CE mark of your products as well as the transition of the new Medical Device Regulation and In-vitro Diagnostic Regulation or the implementation or actualization of your QM system according to ISO 13485:2016.

Our long lasting experience in the Medical Device and Pharmaceutical Industry allows us to guide you to GMP compliance for the production of your Companion Diagnostics, Combination Products, or ATMPs.   

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Company data

Sales volume

1-9 Mio US $

Export content

max. 25%

Number of employees

50-99

Foundation

2002