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Third:  Prepare

Preparing for compliance with the IVD Directive and CE Marking of products may be limited to self declaration procedures depending on the type of products.  However, preparations may also include development and implementation of an ISO 9000 certified quality system and the compiling of a design dossier for certain IVD product families.

No matter whether your products are strictly limited to self declaration, or require ISO 9000 and design dossier certification by a Notified Body, The CRO Group can help with the following:

• Quality Systems
• Technical Files
• Clinical Trials

For a no cost*, no obligation meeting to help you prepare by determining your product groups and quality system requirements for the new IVD CE Mark, please contact us at ivd@crogroup.com.  Or if you are in a hurry, use The CRO Group hotline to find out more about this free service.

*In most cases at your facility, if your facility is within 90 miles of one of our offices.  Otherwise, the meeting may be held at our office most convenient to you, or if you choose, you can reimburse us for travel expenses.

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