Due to the complexity of the medical device and various models makes the process of CE Marking more complicated. Highly reputed consulting team with experiences in CE certification of medical device only can successfully guide you through the entire process.
Below mentioned are the major reasons why a experienced technical consultant is recommended for Medical Device CE mark Consultation and Certification.
- Better understanding of Medical Device
- Previous experience of consulting similar Medical Devices
- Guidance and support in preparing Technical File
- Clinical Evaluation as per latest standard
- Support in conducting Risk analysis
- Quality Management System implementation as per ISO 13485:2003
- Identify the applicable Harmonized standards
- Verify the test report
- Verification of Validation documents
- Label Review
- Identifying the class of Medical Device
- Finding the route of CE Marking
- Prepare the Declaration of Conformity
- Identifying the Notified Body
- Support during Certification audit
- Others like
- Proper guidance on complicated devices like Animal Origin products
- Technical support for critical equipments like Radiation equipments.
- Electro-Mechanical Devicesas per 2007/47/EC
- Software CE Marking
We are not handling Medicinal Device Directive
Advantages by appointing I 3 Consulting
- Qualified and experienced consultants
- Largest customer base in Asia for CE Mark& FDA 510k
- Largest reference standard and document collection
- We take up turn key projects
- Offsite (online) consultancy with very normal fee