We are fully aware of the importance of confidentiality in your line of business and take all necessary measures to protect the confidentiality of your documents and of any information communicated to us.
We can sign confidentiality agreementswith our clients upon request and offer our clients an FTP website as a secure place to share documents while fully preserving confidentiality. In addition, all the professionals involved in your project sign a confidentiality agreement and are bound by our general purchase conditions. They are liable for any disclosure of information.
We can also encrypt emails and files upon request.
Medical Translation in Europe
There are three directives governing the sale of medical devices in the European Union (EU). These directives also determine the translation requirements for those products. Although there are many similarities among the translation requirements, it is important to note that EU members do not have the authority to determine separate requirements for medical devices.
The three directives are:
- 93/42/CEE relates to medical devices - This directive covers a variety of medical devices.
- 90/385/CEE relates to active implantable medical devices - This directive specifically covers active implantable medical devices.
- 98/79/CEE relates to in vitro diagnostic medical devices - This directive covers devices used to analyze tissue, blood, and other fluids.
EU directives use the following scale to classify individual medical devices and accessories based on a device’s capacity to harm patients, users, and other people nearby,
- Class I devices: low risk
- Class II A and II B devices: average risk
- Class III devices: high risk
Translation requirements can become increasingly complex according to their classification. The higher-risk devices in Classes II and III and most of those in Class I require certification by a third party and a representative registered with the EU.