Implement a Quality Management System , if applicable to your device. Most companies use ISO to meet the requirements. Select and appoint a European Authorized Representative to act on your behalf within the EU if you have no physical location in Europe. Prepare a Declaration of Conformity DoC , which states that your device complies with the appropriate Directive. Preparing a complete EU Technical File is now faster and easier. Our services include: Assistance with product classification Verification of applicable standards and testing requirements Technical File or Design Dossier compilation, or review of your files Review of existing marketing materials, labeling, and user manual information to ensure compliance and consistency Verification of compliance with Essential Requirements Preparation of Clinical Evaluation Report based on provided clinical data Implementation, modification, and maintenance of a quality system usually ISO that will meet European and other international requirements Authorized Representative services in Europe Risk assessment and management ISO Development of vigilance and post-market surveillance procedures Contact us to learn how we can help you obtain CE marking for your medical device in Europe.
Request Information from our Specialists All fields are required unless specified. Where are you located? How may we help you? Have questions on what Emergo can do for you? Can't find what you're looking for? Our experts are happy to help. They were decisive from the start and things were well taken care of. I see the problem-solving capacity of Certification Experts as a strength of the company. With future projects, I certainly intend to work with them again. For me it was important how they made everything clear and how they thought along the same lines.
The face-to-face meetings are really important and safe us a lot of time. It is always good to have a partner at hand who can help with profound expertise whenever required. In the future, CE will stay our choice if expert-know-how is needed. We experienced this as a pleasant and valuable result. In addition, Certification Experts swiftly came up with solutions for obstacles we encountered during the certification process.
After reviewing our documentation, they gave us structured feedback and showed us a way forward to compliance with EU directives. The DoC must identify the products within a device family, legal manufacturer, conformity assessment process used, dates of validity, and the DoC must be signed. Annex IX defines the classification rules for Europe. The shortest length of time that one of my clients has been able to achieve for a new CE Certificate is 14 weeks start to a certificate in hand.
The actual review time was only a few weeks, but the company also needed to achieve ISO Certification. More realistic timeframes for review are weeks for high-risk devices.
Still, most Notified Bodies offer options for expedited reviews or dedicated on-site review of Design Dossiers and Technical Files. The requirements for the Declaration vary slightly, but will at least include: Name and address of the manufacturer. Details of the product model, description and the serial number where applicable.
List of CE Marking Directives and standards that have been applied. A statement declaring that the product complies with all of the relevant requirements. Signature, name and position of the responsible person. The date that the Declaration was signed. Details of the authorised representative within the EEA where applicable. Call now Email us. Ask a question.
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