VISAMED Consulting Services for Medical Industries

Clinical Services

Pre-clinical and clinical investigations with added R/D and marketing value

The outcome of the 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 R&D for the development 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 designs and performs 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 14 essential requirements (Medical Device Directive, 93/42/EEC, Annex I,) and international regulatory filing.

VISAMED coordinates the following activities:

• 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:

• selection of the appropriate clinical strategy
• selection of suitable investigators
• Design of clinical plans and conformity with the European harmonized standards EN 540
• Insurance coverage
• Applications/Notification to Ethical committees and European competent authorities
• Study initiation and monitoring
• Data management and analysis

Send mail to info@visa-med.com with questions or comments about this web site.