Medical Device CE Marking - CE Mark Consultants





QARA is a special product designed to help CE Marking of medical devices manufactures across the world to provide technical support to comply with European regulatory requirements.

If you are planning to sell your product in Europe you need to affix CE Mark on the product. No matter, the country of origin!!!

QARA and its special features helps the client to affix CE Mark at the comfort of Home OR Office or wherever He /She is ...

Once you register with QARA we will appoint the CE Mark consultants to take up your project on a fixed amount and time line. Weekly update will be send to top management about the status of the project.

All our CE Mark consultants are English speaking and highly experienced in CE Marking of medical devices domain.

MEDICAL DEVICE CE MARKING

The unique feature of QARA enables you to affix medical device CE mark on your products fast and economic way.

QARA team share the knowledge with clients, guide to reach the destination fast with less effort without deviating from the regulatory requirments. We prepare the technical file on behalf of client in cloud and directly submit to notified Body. This special feature saves lot of time and unexpected delays.

No matter where you are OR where we are....

Contact us to get started.

 





 

 

How to achieve CE Certificate for your medical device CE mark


  • Identify the device for CE Marking
  • Appoint experienced consultants
  • Decide the directive, class and routé of CE Marking
  • Implement ISO 13485
  • Conduct Risk analysis
  • Perform safety and functional testing
  • Perform clinical evaluation
  • Perform critical process validations
  • Prepare Technical file / Design dossier
  • Appoint a Notified Body
  • Submit technical file for Notified Body Review
  • Answer to Notified Body Concerns and update the technical file
  • Notified Body site audit
  • Affix CE Mark on your product.

 

 

How we help you to achieve CE Mark


  • Request us for official proposal
  • Fill the Quote Request Form online ( QRF)
  • QARA Consultant will contact you over phone to explain about the process.
  • Make the advance payment
  • We will allocate the consultant
  • Client should depute one person to coordinate with consultant
  • Consultant will guide step up step and prepare Technical file
  • Client should arrange all the in house documents
  • Consultant will help to Identify the Notified Body
  • Submission and coordination with Notified Body
  • Coordinate during the date of audit.
  • Affix CE Mark on your device.
  • More info

 

Technical Consultancy Fee

Activity Class of  Medical Device
1 1s/m 11a 11b 111
Complete Technical file / Design Dossier preparation $ 1000 $ 1200 $ 1400 $ 1600 $ 2200
Animal Origin Devices - Technical file / Design Dossier preparation - - $ 1500 $ 1800 $ 2500
Medical Software - Technical file / Design Dossier preparation $ 1000 $ 1600 $ 1800 $ 2000 $ 2400
Support in closing NB reviewer comments $ 400 $ 500 $ 600 $ 700 $ 800
If Required,  travelling to client location and lodging Additional

 

Notified Body Fees for budgetary purpose only.

Activity Class of  Medical Device
1s/m 11a 11b 111
Technical file / Design Dossier Review $ 2500 $ 3500 $ 4500 $ 5500
Site Audit $ 1000 $ 1250 $ 2000 $ 2500
Issue of Certificate $ 500 $ 500 $ 500 $ 500
Travelling and Lodging Yes Yes Yes Yes

 

Payments

All payments to be made to I 3 Consulting as per the details mentioned in invoice.

Payments in 4 equal installments.

 

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