Quick Contact
IVDR CE Marking Service in Chicago
For the most accurate and up-to-date information regarding regulatory requirements and IVDR CE Marking in Chicago, manufactures and exporters may consult with experts specializing in in-vitro diagnostic device regulations and product compliance.
IVDR (In Vitro Diagnostic Medical Devices Regulation) CE marking services are offered by regulatory consulting firms like I3CGlobal to assist manufacturers in achieving compliance with the requirements of the IVDR.
It’s essential for manufactures selling Reagents, kits, equipment’s, IVD software products in Chicago to ensure compliance with the relevant EU regulations, which may include obtaining the CE Certification from EU notified bodies. This often involves working closely with regulatory bodies and possibly engaging with third-party conformity assessment bodies.
IVDR CE Marking Consultants Role
We are regulatory consultants play a crucial role in the IVDR CE Marking or certification process.
- MDQMS – EN ISO 13485:2016/ BS ISO 13485:2016 implementation support
- ISO 14971 Risk Analysis Implementation and documentation
- Biological Evaluation plan and reporting
- Clinical and Performance Evaluation Guidance and documentation.
- Usability Studies related to IVD equipment’s and tests kits
- Process Validations
- IVDR Technical Documentation File
- Interaction with IVDR Notified Bodies
Outsource IVDR Regulatory to I3CGlobal
Outsourcing IVDR CE Marking regulatory services, offers several benefits to IVD manufactures in Chicago and other parts of United States
- I3CGlobal team of IVDR expertise help manufactures avoid technical mistakes and thereby reduce the delay in IVDR certification process.
- Our teams extensive knowledge and experience in IVD regulations ensure compliance much faster
- Outsourcing regulatory services offers cost savings over hiring in-house experts, reducing overhead
- Companies can focus on core activities while experts handle MDR compliance, speeding up product launches
- Consultants maintain and update documentation.
- I3CGlobal networks with regulatory authorities and Performance testing labs streamline interactions, expediting approvals.
Outsourcing IVDR regulatory services for invites diagnostic devices boosts efficiency, cuts costs, and lowers risks. It speeds market access, aiding product success and business growth.
Frequently Asked Questions
IVDR CE Marking Timeline
- Class C & D devices typically require 4 to 5 months extensive performance evaluation and documentation, leading to a longer certification process
- Class B, C & D the involvement of a Notified Body is mandatory, so the timeline of TF assessments, conducting audits, and awaiting feedback will consume around 6 to 8 months.
While a 12 month timeline is typical for IVDR CE certification. Actual durations can vary based on product features. Experienced regulatory consultants like I3CGlobal can optimize timelines and ensure compliance, facilitating a smoother IVDR certification journey.
What is the process of IVDR Technical documentation and file preparation?
Indeed, it’s crucial for the manufacturer to furnish all technical and production related data to consultants for compiling the IVDR technical documentation. This file encompasses detailed information regarding the design, manufacture, and performance of the IVD device. It includes specifications, drawings, risk assessments, performance evaluation reports, test reports, and other pertinent documentation.
This collaborative approach ensures that the IVDR technical documentation meets regulatory requirements and supports successful certification. Sharing documents through cloud platforms facilitates transparency and real-time collaboration among stakeholders, streamlining the process.