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Services: Medvance is a specialist medical device consultancy group providing regulatory and clinical research services to clients on a global basis.
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Medvance is a specialist medical device consultancy group providing regulatory and clinical research services to clients on a global basis.

Medical device clinical and regulatory consultancy group.

Full description

Medvance is a specialist medical device consultancy group providing regulatory and clinical research services to clients on a global basis. Our clinical services include:

  • Production of all the documentation you will require for your study including:

          Investigator Brochure
          Clinical Investigation Plan (protocol)
          Case report forms
          Patient consent documents
          Institution agreements
          Study master file
          Investigator site files

  • Clinical Evaluation/Literature Review
  • Advice on study design
  • Statistics
  • Research Ethics Committee submissions
  • Competent Authority Submissions
  • Selecting appropriate study sites
  • Study initiation visits
  • Study monitoring
  • Study close down
  • Data management
  • eCRF
  • Report writing (final report, publications, presentations)
  • Obtaining study insurance
  • Translation of study documents
  • Clinical Evaluations
  • Auditing

Medvance also provides a range of bespoke training solutions to medical device companies including ISO14155, post market surveillance and the differences and similarities between device and pharmaceutical clinical research.
Regulatory services include:

  • CE Marking process
  • Liason with Competent Authorities
  • Notifications for clinical investigations
  • Clinical auditing services
  • Clinical SOP writing
  • Assistance in producing standard operating procedures

 

Related reports

Market Research Reports provided by reports.innovaro.com
Economic Benefits and the Drive for Going Green Bolstering Medical Device Reprocessing
May 2010 - 8 pages - $500
European Union (EU) Medical Device Directive (MDD) Changes: Industry Impact Analysis
Apr 2010 - 6 pages - $500
The True State of the Medical Device Industry
Feb 2009 - 242 pages - $690
FDA Changes Suggested in 510(k) Process - Impact and Opportunities
Apr 2011 - 11 pages - $500
Austria Medical Equipment Market Profile
Jan 2011 - 11 pages - $500
European Medical Devices Industry: An Impact Analysis of the Changing Regulatory and Health Economics Scenarios
Jan 2011 - 8 pages - $500
Medical Device Company Performance Tables
Mar 2010 - 414 pages - $690
Changing Regulatory and Health Economics Scenarios in Europe - An Orthopedic Devices Industry Perspective
Feb 2011 - 9 pages - $500
The Medical Device Reprocessing Industry: Increasing Hospital Sustainability
Jun 2009 - 17 pages - $500
Smiths Medical Medical Device Company Intelligence Report
Jan 2011 - 38 pages - $515
More Related Market Research Reports >>>

Service contact

Janette Benaddi
CEO

Contact directly

Company details

Medvance Ltd

Medvance is a leading global clinical research and regulatory services provider supporting the medical device and healthcare industries worldwide.

View profile
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Related categories

Services
Clinical and scientific
Clinical research organisations (CROs)
Consultancy
Human resources

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