CEISO
CEISO is a company with nearly 25 years of experience in the medical sector, specializing in consulting, clinical services, training, and market access for medical devices. They support companies in design, development, post-market surveillance, regulatory compliance, and market entry both in France and internationally. Their mission is to help clients understand and adapt to evolving regulations, ensuring safety, performance, and compliance of medical devices throughout their lifecycle.
Industries
Nr. of Employees
small (1-50)
Products
E-learning platform (on-demand regulatory training)
On-demand e-learning platform offering modular courses covering EU MDR/IVDR, UDI/EUDAMED, clinical evaluation, post-market surveillance, quality systems, risk management, sterilization and software validation; available 24/7 with interactive content and scheduled Q&A sessions.
E-learning platform (on-demand regulatory training)
On-demand e-learning platform offering modular courses covering EU MDR/IVDR, UDI/EUDAMED, clinical evaluation, post-market surveillance, quality systems, risk management, sterilization and software validation; available 24/7 with interactive content and scheduled Q&A sessions.
Services
Preparation, review and submission of technical and regulatory dossiers for CE marking (MDR/IVDR), conformity assessment support and regulatory gap analyses.
End-to-end clinical investigation services including study design, regulatory submissions, site selection, monitoring, data management, statistical analysis and study close-out.
Design and implementation of post-market surveillance plans, vigilance reporting and periodic safety/performance reporting in compliance with MDR/IVDR.
Provision of an EU-based authorised representative and outsourced person responsible for regulatory compliance to act on behalf of manufacturers and support regulatory contact points.
Assistance to implement and maintain QMS aligned with ISO 13485 and ISO 9001, internal and supplier audits and support for certification readiness and inspection responses.
Regulatory, clinical and quality training delivered in-person, as virtual classes or via an on-demand e-learning platform with modular courses covering MDR/IVDR, UDI/EUDAMED, risk management, clinical evaluation, sterilization and software validation.
Preparation, review and submission of technical and regulatory dossiers for CE marking (MDR/IVDR), conformity assessment support and regulatory gap analyses.
End-to-end clinical investigation services including study design, regulatory submissions, site selection, monitoring, data management, statistical analysis and study close-out.
Design and implementation of post-market surveillance plans, vigilance reporting and periodic safety/performance reporting in compliance with MDR/IVDR.
Provision of an EU-based authorised representative and outsourced person responsible for regulatory compliance to act on behalf of manufacturers and support regulatory contact points.
Assistance to implement and maintain QMS aligned with ISO 13485 and ISO 9001, internal and supplier audits and support for certification readiness and inspection responses.
Regulatory, clinical and quality training delivered in-person, as virtual classes or via an on-demand e-learning platform with modular courses covering MDR/IVDR, UDI/EUDAMED, risk management, clinical evaluation, sterilization and software validation.
Expertise Areas
- Clinical trial management and CRO services
- Clinical evaluation and performance studies
- Regulatory compliance and CE marking (MDR/IVDR)
- Quality management systems (ISO 13485 / ISO 9001)
Key Technologies
- E-learning platform and learning management systems
- EUDAMED / UDI registration systems
- Clinical study protocol design and statistical analysis
- Post-market surveillance frameworks (PSUR / SSCP)
News & Updates
CEISO Academy Launch
Introduction of CEISO's e-learning platform to facilitate understanding and implementation of EU regulations for medical devices.
Regulatory Updates
Latest updates on EU MDR and IVDR regulations, including transitory provisions and new guidelines.
Understanding EU MDR and IVDR
An overview of the European regulations for medical devices and in vitro diagnostics, and how CEISO supports compliance.
Post-Market Surveillance Best Practices
Guidelines and strategies for effective post-market surveillance of medical devices.
ISO 13485 Certification
CEISO is certified ISO 13485 by AFNOR Certification, demonstrating compliance with quality management standards for medical devices.
Qualiopi Certification
CEISO is certified Qualiopi for its training activities, ensuring high-quality training processes.
CEISO Academy Launch
Introduction of CEISO's e-learning platform to facilitate understanding and implementation of EU regulations for medical devices.
Regulatory Updates
Latest updates on EU MDR and IVDR regulations, including transitory provisions and new guidelines.
Understanding EU MDR and IVDR
An overview of the European regulations for medical devices and in vitro diagnostics, and how CEISO supports compliance.
Post-Market Surveillance Best Practices
Guidelines and strategies for effective post-market surveillance of medical devices.
ISO 13485 Certification
CEISO is certified ISO 13485 by AFNOR Certification, demonstrating compliance with quality management standards for medical devices.
Qualiopi Certification
CEISO is certified Qualiopi for its training activities, ensuring high-quality training processes.