CE marking and international marketing authorisation

Swift and safe marketability

You want to bring your newly developed medical device to market as fast as possible? We accompany you along the path to CE marking and to international marketing authorisation and registration.

Conformity assessment procedure and CE marking

The CE marking proves that your device conforms to the requirements of Community Law. We will be glad to support you with

• Determination of purpose
• Demarcation issues
• Consultation procedures
• Classification
• Risk management
• Clinical evaluation
• Essential requirements

We will assist you throughout the conformity assessment procedure until your CE marking is secured.

US marketing authorisation

Which submission documents does the FDA require from you for a premarket notification (510(k))? Which documentation and process descriptions must you keep on hand for an audit or an inspection? What does the Quality System Regulation (QSR) require of your company?

We will assist you in the fulfilment of the FDA requirements and ensure your success with regard to

• Establishment registration and medical device listing
• FDA submission (premarket notification - 510(k))
• Labelling requirements
• 510(k) exempt
• Quality System Regulation (QSR)
• Preparation for QSIT inspections

International marketing authorisation – international registration

Which documents do you need for the international registration of your devices in, for example, Canada, Mexico, Australia or South-East Asia?

We ensure that your device makes its way on to the international market.

Do you need support with CE marking or international marketing authorisation?

We will assist you in complying with the currently valid guidelines

• 90/385/EEC on active implantable medical devices (AIMD)
• 93/42/EEC on medical devices (MDD, 2007)
• 98/79/EC on in vitro diagnostic medical devices (IVDD)

In addition, we will help you to fulfil international marketing authorisation conditions.