Nexialist
Nexialist is a consulting company specializing in regulatory intelligence and compliance for health products, including medical devices, in vitro diagnostics, and innovative therapies. They support clients through all process stages such as regulatory watch, advice, audits, technical documentation, compliance, personnel training, and more. Their mission is to guide companies in navigating complex regulatory environments, ensuring product conformity and excellence.
Industries
Nr. of Employees
small (1-50)
Nexialist
La Ciotat, Provence-Alpes-Cote d'Azur, France, Europe
Products
Regulatory monitoring platform
A regulatory monitoring and normative surveillance platform that aggregates regulatory updates, guidance and analyses for medical device and IVD stakeholders. The platform is supported by a curated proprietary regulatory reference database reported to contain over 8,000 international references and provides thematic syntheses and alerting.
Regulatory monitoring platform
A regulatory monitoring and normative surveillance platform that aggregates regulatory updates, guidance and analyses for medical device and IVD stakeholders. The platform is supported by a curated proprietary regulatory reference database reported to contain over 8,000 international references and provides thematic syntheses and alerting.
Services
Ongoing monitoring of regulatory and normative changes, synthesis of guidance documents and tailored strategic recommendations for device and IVD stakeholders. Service is supported by a curated proprietary regulatory reference database.
On-site and remote audits to assess quality management system conformity, supplier controls and sterilization processes. Mock audits simulate regulatory inspections and audit readiness, available in tiered packages to fit organisational needs.
Review and optimisation of technical documentation and submission dossiers for devices and IVDs to improve completeness and compliance prior to submissions and conformity assessments.
Design, implementation and optimisation of quality management processes to align with ISO 13485 and applicable regulatory requirements, including audit readiness support.
Preparation of clinical evaluation reports, PMCF planning and management of post-market surveillance activities to generate and maintain clinical evidence across the product lifecycle.
Validation planning and assessment for manufacturing processes and sterilization cycles, including protocol development, execution oversight and regulatory-compliant reporting.
Ongoing monitoring of regulatory and normative changes, synthesis of guidance documents and tailored strategic recommendations for device and IVD stakeholders. Service is supported by a curated proprietary regulatory reference database.
On-site and remote audits to assess quality management system conformity, supplier controls and sterilization processes. Mock audits simulate regulatory inspections and audit readiness, available in tiered packages to fit organisational needs.
Review and optimisation of technical documentation and submission dossiers for devices and IVDs to improve completeness and compliance prior to submissions and conformity assessments.
Design, implementation and optimisation of quality management processes to align with ISO 13485 and applicable regulatory requirements, including audit readiness support.
Preparation of clinical evaluation reports, PMCF planning and management of post-market surveillance activities to generate and maintain clinical evidence across the product lifecycle.
Validation planning and assessment for manufacturing processes and sterilization cycles, including protocol development, execution oversight and regulatory-compliant reporting.
Expertise Areas
- Regulatory strategy and intelligence for medical devices and IVDs
- Quality management systems (ISO 13485) implementation and auditing
- Conformity assessment and notified body interactions
- Clinical evaluation, PMCF and performance study design
Key Technologies
- ISO 13485-aligned quality systems
- Clinical performance study methodologies and PMCF frameworks
- Software as a Medical Device (SaMD) regulatory assessment
- AI components in regulated medical devices
News & Updates
Nexialist - your partner for medical device compliance
Company profile and services overview.
New services for medical device compliance
Introduction of Aquila, Phaos, Pyxis, Nexinform, and other tailored solutions.
Regulatory updates and publications
Latest news, publications, and regulatory guidance documents.
Understanding the MDR and IVDR regulations
An overview of the new European regulations for medical devices and diagnostics.
Impact of Brexit on medical device regulation
How Brexit affects compliance and market access.
The importance of clinical evaluation in medical device approval
Guidance on clinical data requirements and evaluation processes.
Nexialist - your partner for medical device compliance
Company profile and services overview.
New services for medical device compliance
Introduction of Aquila, Phaos, Pyxis, Nexinform, and other tailored solutions.
Regulatory updates and publications
Latest news, publications, and regulatory guidance documents.
Understanding the MDR and IVDR regulations
An overview of the new European regulations for medical devices and diagnostics.
Impact of Brexit on medical device regulation
How Brexit affects compliance and market access.
The importance of clinical evaluation in medical device approval
Guidance on clinical data requirements and evaluation processes.