We use regulatory consulting as an umbrella term for a diverse set of services related to medical device regulatory compliance. Due to changes and demanding requirements medical device regulations are becoming increasingly difficult.

CE Medical helps you with:

• Regulatory assessment & strategy
• Medical device classification
• Support with European, US and Chinese regulatory requirements
• Registration CE, FDA & CFDA
• Certificate verification
• Product compliance check
• Notified Body selection
• Legal Representation
• Essential requirements review
• Audit preparation
• QMS compliance
• Determining regulatory responsibilities and obligations
• Notified body selection
• GAP-analysis

Medical device regulations are becoming increasingly difficult. Dealing with changes in requirements in medical device regulatory compliance Compliance issues in audits or submissions

You can use CE medical as you temporary support during short or long term projects. We can provide this service at your location or externally depending on your needs.

• Regulatory strategy
• Notified body selection
• GAP-analysis
• Registration CE, FDA & CFDA
• Legal Representation
• Technical dossier set-up
• Preparation of clinical evaluation reports