CE Marking Consultants assist new medical device manufacturers in bringing a new device to the EU market or transitioning an existing medical device Technical File to MDR. See how we can assist you in the sections below. The medical device industry is aware of the difficulties in obtaining CE Marking for in vitro diagnostics and medical devices.
The new medical device regulation (MDR) and the in-vitro diagnostic regulation (IVDR) require more detailed documentary evidence to show that your device is safe, efficient, and performing as intended by the manufacturer. Therefore, we highlight some of the most important factors and benefits we believe manufacturers should be aware of before hiring CE Marking Consultants.
MDR Technical Documentation/File GAP analysis.
Send us your current technical documentation (TCF), and we’ll help you figure out what’s missing and what needs to be added. Our medical device consultants will examine your device’s design, risk analysis, biological safety, electrical safety, clinical evaluation, testing reports, post-market surveillance, labeling, and other areas in detail, providing a clear picture of any gaps and the steps that need to be taken.
MDD to MDR Transitioning of existing Technical File(s).
Manufacturers must now demonstrate their devices’ safety, efficacy, and performance through technical documentation under the new EU Medical Device Regulation (MDR). However, we discovered that many manufacturers who currently hold a CE certificate under the MDD do not have sufficient supporting technical documentation to comply with the new Medical Device Regulation (MDR).
As medical device consultants, we can thoroughly examine your existing technical file and replace any low-quality content with high-quality content, particularly in clinical evaluation reports, post-market surveillance, post-market clinical follow-up, risk files, and public information pages. Stared in 1999, a deep rooted medical device CE Mark Consultants team specializes in all types and risk class. I3CGlobal has established partner networks and offices in the EU, India, the United States, and the United Arab Emirates. Manufacturers, already our customers, see us as outsourcing partners for medical device regulatory compliance throughout the year rather than consultants.
Steps followed by CE Marking Consultants
- Understand the device and identify applicable regulatory requirements and device risk class.
- Identify equivalent devices with the help of the client team.
- Identify the route of CE Marking.
- Biological & Safety assessment for external tastings.
- Start drafting the technical file.
- Planning for Post-Market Surveillance.
- Planning for Post-Market Clinical Follow up
- Planning for Clinical evaluation.
- Review and updating of Risk Management files and Usability records.
- Support in Quality Management System implementation as per ISO 13485:2016.
- Review and suggestions on verification & validation documents and reports.
- Label review as per ISO 15223-1.
- IEC 62304 Implementation support (Software CE Marking)
- Support in identifying the Notified Body
- Final Review and submission of technical file to the notified body
- Answering notified body review comments
- Support during certification and annual surveillance audits.
Advantages of outsourcing technical documentation and maintenance with us
- We have a worldwide network and team of CE Marking Consultants, lead auditors & medical writers.
- Largest customer base in Asia for medical device CE marking & USFDA 510k.
- We handle all types of new or patented devices!! Handles any risk class!
- One-stop solution for medical device testing.
- One-stop solution for medical device European authorized representative
- One-stop solution for medical device European free sale certificate.
- Retrospective Post Market Clinical Follow up study
- In-house clinical evaluators
- We support drug-device combinations and active implantable devices.
- Cloud documentation. Clients can access and monitor the progress 24 x 7 from anywhere.
- No worries about employees leaving the organization. Your files are in safe hands throughout the year.
- Onsite & offsite medical device CE Consultancy Services. World’s most economic service provider!!