Foreign manufacturers must appoint an EU Authorized Representative (AR) before they can sell their medical devices and IVDs in Europe.
In addition to acting as a liaison with the European national Competent Authorities, the EU AR is responsible for verify the technical documentations, regulatory compliance, Declaration, Labeling etc.
Before market and during Product Lifetime maintain a copy of the technical documentation and CE certificate, Provide a current copy of your Technical File or EU Declaration of Conformity to Competent Authorities up on request& inform Manufacturer about complaint.
The EU AR acts as the manufacturer’s regulatory representative in the European Single Market and is the point of contact between the manufacturer and the European national Competent Authorities. The EU AR is also referred to as an EAR, EC Representative, EC Rep or Authorized Representative. The MDR/IVDR increased the responsibilities of the EU AR. One significant change is that the AR now explicitly shares liability with the manufacturer for products on the market.
We help start-up medical device companies who wants to accelerate their ISO 13485:2016 QMS implementation and ISO Certification.
We can provide consulting services to help with your ISO 13485:2016 Quality Management System implementation. The consulting can be tailored to meet your needs and can include assisting with the gap, analysis and planning, helping with each step of the implementation, and support with the ISO Certification process.
Conducting an ISO 13485 quality management systems Gap Analysis is a critical first step for good implementation planning. Our free download checklist which also covers FDA quality system regulations, along with our experienced consulting help can provide you with the resource to get this done quickly.
After the Gap Analysis is complete the next step is to develop the implementation plan for your medical device QMS. Our download Planning Kit designed by ISO 13485 experts, provides guidance on developing the implementation plan for your medical device manufacturing QMS. The plan will include all steps up to and including iso certification.
Includes QMS consultancy help with the implementation by providing through our website store, templates for SOP’s and quality manual. We then help to customize the documents to suit your medical device. Also provide QMS training for your employees, conduct audits and help with any corrective actions. This fast-track approach can save 6-9 months overall.
We can partner with you to provide coaching and support for the ISO Certification process. Including advice on the selection of a recognized certification body, training of your employees on what to expect & how to behave during the certification audits. Certification is a multi-step process so planning is important & we can advise and assist with this final step.
Our Lead Auditors can conduct internal audits during the implementation process and as SOP’s are implemented. Also provide training and coaching for your own internal audit team as required. Assist with identifying improvement opportunities and corrective actions and to help prepare for the ISO certification audits.
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