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Medical and Diagnostic Devices: Regulatory Approvals and CE marking

The latest medical and diagnostic device directives state that a product requires CE marking before placing it on EU market. This applies also to medical software. The directives give companies "essential requirements", which must be fulfilled before the CE mark can be applied. Depending on the device category, it may require an audit by a notified body prior to the CE marking process.

Honkasalo Systems has worked over 15 years in the medical and diagnostic device sector and we know all related laws, regulatory requirements and standards. We can offer You our long practical experience in commercializing medical products in the EU market. We are a business oriented company and understand that the CE marking and related documentation and processes should serve the business and not vice versa. Together we can find a way that You can fulfill the EU regulatory requirements without compromising Your business needs.

Our service includes:
  • Assessment, if the product is regulated by the EU directives
  • Mapping gaps between current and required features, documents and processes
  • Implemenation of any corrective actions found during the gap analysis
  • Driving the CE marking process
  • Training the personnel in regulatory matters
Our services also include assessment of FDA requirements for medical and diagnostic products and the related registration process.

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