Medical Device CE Marking
The CE Mark Certificate is mandatory requisite for all Medical Devices manufactured and marketed in European Economic Area (EEA). The CE Mark Certificate is a proof of compliance with essential requirements of the Medical Device Directive(MDD).
The Notified Body is permitted to assess whether a Medical Device meets certain standards and issue CE Certificate. A Notified Body is an organization that has been accredited by a Member States in Europe
Compliance to Medical Device CE Marking is a difficult task. Manufactures and private label manufactures should appoint experienced CE Marking service consulting companies to accomplish the objective on time.
Medical Device CE Mark is widely accepted across doctors and healthcare practitioners across the globe as a mark of quality. CE Marking Medical Device - Most manufactureres in medical electronics, medical software, active medical device, Implant(s), Large medical equipment's go for CE Certification.
The major hurdles in medical device CE Marking are the following
Identification of Harmonized Standards.
Identification of medical device class and rule justification.
Identify external laboratories for conducting the tests.
Preparation of Technical File.
Identify Notified Body.
Technical File submission, Coordination and Onsite Audit.
ISO 13485 Implementation.
Benefits of our CE Marking Service.
Turnkey service with assured CE certificate.
Any Notified Body of choice can be arranged for the CE Certification.
Good reputation among leading Medical Device CE Mark Notified Bodes across the Globe.
Worldwide offices and associated Laboratories.
Experienced CE Marking Medical Device Consultants.
ISO 13485 and CE Marking - Certified lead Auditors as project Managers and Consultants.
Low Fees, FAST Processing.
Our CE Marking service ( Medical Device CE Marking) are designed to easy project completion by the use of external Cloud to work multiple people on the same project.
Medical Device CE Mark Certificate- How much it Cost?
The Cost of CE Marking depends on the following factors
Intended Use/ Application of the Medical Device.
Type and Models of the Medical Device planning for CE Certification.
Notified Body selected for CE Certification.
Standards Identified and there testing and reputation of external Laboratories selected for Testing.
CE Certification consultants fees based on Class and number of Models/Variants.
CE Marking Medical Device - A good technical CE Marking Consultant can help you to reduce cost of project.
To get CE Marking Service fees contact our office location near to you for with below information..
Medical Device(s) name for CE Marking.
Application / Intended use of the Medical Device.
How many models variants to be included in the CE Mark Certificate..
If you know the class of the Medical Device please mention.
Are you looking for CE Marking Consultants.
Are you looking for Notified Body.
Have you implemented 13485 in your organization.
Contact us for more information Write to us