Guideline for Monitoring of Revision of the Medical Devices Directive 93/42/EC

Are you sure that you fulfill all requirements of the revised 93/42/EC? Did you have to change the product classification and does this have an effect on the conformity assessment procedure? Did you inform your  Notified Body about the changes?

Did you consider all issues of new requirements of the revised 93/42/EC? Did you evaluate the risk of ergomic features and validate the usability?

You can check and clarify this and many other relevant requests of the new requirements of the revised 93/42/EC with our solution.

Our clearly and easily presented guideline provides you the opportunity to perform a complete review of the relevant essential new requirements for your product.

Benefits to you

• Planning reliability and  decision guidance
• Demonstration of relevant interfaces
• Monitoring of relevant new requirements
• Precise advise on important information for fulfillment of product conformity

Description

The guideline is based on an interactive graphic web model which highlights the new important requirements and it`s apects. The correlation of different fields as well as interfaces to Notified Bodies and governing bodies are presented. Relevant documents of the European Commission, updated MEDDEV documents and list of harmionized standards are linked.

Target groups

• Manufacturers of medical devices,
• QM representatives and Regulatory Affairs Managers,
• European representatives,
• Distributors,
• Importers,
• Suppliers, and  
• Companies that develop, produce, maintain, sell or prepare medical devices

Consultation

We will gladly present our solution: "Guideline for Monitoring of Revision of the Medical Devices Directive 93/42/EC” to you, and advise you on this topic.

Costs

The costs of the solution are € 199.- plus tax.

Interested? Please contact us.