Neox understands the unique requirements of medical device clinical trials. Our dedicated team supports our clients in all aspects of the study, from design to complete trial close-out:
- Drafting investigational plans
- Thorough preparation of all essential documents
- Legal support during the contract negotiation
- Intensive and regular communication with regulatory authorities and ethics committees
- Monitoring services
- Development of customized clinical database
- Development of the pharmacovigilance system
- Statistical analysis
Our global offices across Europe orchestrate to identify experienced healthcare providers for our clients. We aim for reliable, high-quality clinical data while meeting all defined timelines. Our expert services have been validated time and time again from both national and international regulatory authorities and independent auditing companies.
- RA/QA Consulting
- EU Medical Device Classification
- EU Authorized Representative
- Technical File Compilation
- Clinical Evaluation Reports
- Post-marketing surveillance
- ISO 13485 Implementation
1. RA/QA Consulting
EU Medical Device Classification
- The determination of which directive applies to your product. Devices can fall under the Medical Devices Directive (MDD) 93/42/EEC, Active Implantable Medical Devices Directive (AIMDD) 90/385/EEC or In Vitro Diagnostic Directive (IVDD) 98/79/EC
- Classification of the product according to safety into classes I-III
- Verification of applicable standards and testing requirements
2. EU Authorized Representative
If your company does not have a physical location in the EU, you are required to appoint an independent Authorized Representative to represent your company to European authorities. You must retain an EC REP as long as you sell your devices in Europe.
- Assist with certain device registrations, as required
- Be identified on your product labeling throughout Europe
- Make a current copy of your Technical File or CE Declaration of Conformity available for inspection by a Competent Authority, upon request
- Assist with Incident and Field Safety Corrective Action (FSCA) reporting, in cooperation with you and your distributors
3. Technical File Compilation
We specialize in helping medical device and IVD companies achieve CE Marking certification and determine exactly which materials need to be compiled.
- Completely review all existing documentation in support of meeting the applicable Essential Requirements of the Directive(s). Evaluate and identify gaps or deficiencies in your documentation.
- Compile your EU Technical File or Design Dossier, with internal peer review.
- Determine applicable testing requirements and standards for your device.
- Review your clinical data, compile a Clinical Evaluation Report (CER), and facilitate a Risk Assessment as necessary.
- Review of existing marketing materials, labeling, and user manual information to ensure compliance and consistency
- Assist with the MDR/IVDR transition process
4. Clinical Evaluation Reports
Clinical evaluation reports are an important step in the path to CE Marking. Many manufacturers struggle to comply with European CER requirements - but Neox has the experience with CE regulations and medical device clinical trials to help you prepare a fully compliant CER.
- Gather and analyze appropriate scientific literature applicable to your device.
- Compile and draft the CER in compliance with EU requirements.
- Develop procedures to compile CERs and perform clinical literature reviews for future updates to your CER.
- Develop a protocol to methodologically search and evaluate journal articles and provide a synopsis
5. Post-marketing surveillance
Neox is equipped to act as your compliance partner long after your device goes on the market. We can help you design and implement a PMS system that meets requirements in multiple markets and navigate regulatory challenges throughout the device lifecycle.
We can help determine when incidents are reportable and ensure vigilance reports are completed on time and in compliance with local requirements.
6. ISO 13485 Implementation
We'll help you implement ISO 13485 or upgrade from ISO 9001.
- Full customization of your ISO 13485 quality system
- Check for readiness for the certification audit
- We can recommend qualified third-party testing and certification firms that specialize in your device category.
- Neox will perform on-site ISO 13485 training for your key employees as part of the implementation project.