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Pre-Clinical and Clinical Investigations
The outcome of pre-clinical investigations can be used to get early customer feedback on products. This feedback can be used to improve your product design, to define your marketing strategy and your product positioning. Furthermore, a properly design clinical study should support the marketing strategy and help Research and Development for the creation of next generation product. In conclusion, pre-clinical and clinical investigations with added R/D and marketing value can help you to develop and introduce to the market a superior product in a timely manner.
Pre-clinical investigations
To ensure a successful development and launch of your new or modified products, VISAMED offers you the possibility to evaluate your products using in vitro and in vivo models. VISAMED can help you in designing and performing bench test and acute and/or chronic animal studies. Those studies can serve as product design verification and validation. As a result, those studies will support the essential requirements (Medical Device Directive, 93/42/EEC, Annex I) and global regulatory filing.
VISAMED provides the following services:
 Identify standards/guidelines and requirements for in vitro and in vivo testing
Develop product testing strategy in compliance with identified requirements
Design, coordinate and/or perform testing
Clinical Investigations
VISAMED can help you to manage your clinical study by assisting you with:
the selection of the appropriate clinical strategy
the selection of suitable investigators
the Design of clinical plans and conformity with the European harmonized standards EN ISO 14155
series
the Insurance coverage
the Applications/Notification to Ethical committees and European competent authorities
the Study initiation and monitoring
the Data management and analysis
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Tel. +49(0)721-4764847