New nexialist service
AQUILA, gaining altitude to optimize your organization.
Choose a comprehensive range of tailor-made audits to help your company reach new heights.
Led by a team with complementary expertise, our sherpa-auditors will guide you to the top by challenging ideas and fostering discussion, ensuring smoother interactions with your Notified Body.
AQUILA®
The eagle’s vision
and precision
for a beneficial audit.
A contradictory audit based on sharing to grow and learn.
But why contradictory? At nexialist, we believe in the power of dialogue and that by challenging and confronting ideas, you will be better prepared for discussions with your Notified Body.
Our team of auditors, certified as IRCA Lead Auditor 13485, supports you across a wide range of technical areas.
Whether it’s internal audits, subcontractor audits, sterilization audits, or mock audits, the strength of our auditors lies in their complementary skills and expertise. This ensures a comprehensive audit, helping you reach the highest standards.
Certified IRCA Auditor 13485
our team
our philosophy
christophe
elsa
savéria
laetitia
yani
lucie
our main
Areas of Intervention
ISO 13485:2016
Medical Device/IVD Regulations
Process Validation – Sterilization
MDSAP – FDA 21 CFR
Production
Software (SaMD) – AI
Electromedical
Design
Good Manufacturing Practices/GMP/GxP
Cosmetics
The
of nexialist
Types
of audits
Internal
audits
The QMS internal audit assesses your organization’s compliance with ISO 13485 and other applicable regulatory and normative frameworks. It identifies gaps, optimizes critical processes such as risk management and traceability, and ensures readiness for external audits.
Supplier
audits
The QMS internal audit evaluates your organization’s compliance with ISO 13485 and other applicable regulatory and normative standards. It identifies gaps, optimizes critical processes such as risk management and traceability, and prepares for external audits.
Sterilization
audits
The sterilization audit ensures the compliance of processes with standards and regulations. It verifies controls, traceability, and effectiveness, guaranteeing the safety of sterile medical devices.
mock audit
audits
The mock audit simulates an audit to assess compliance and identify gaps. It effectively prepares teams and processes for official international inspections (FDA, MDSAP, Europe, etc.).
Why AQUILA ?
Few
figures
our solutions
A complete
range
Eco, Business, and First, PHAOS tailors its offerings to your needs through three different packages.
Choose the one that best fits your expectations.
Is your package ready?
Contact our sherpas
New nexialist service
AQUILA, gaining altitude to optimize your organization.
Choose a comprehensive range of tailor-made audits to help your company reach new heights.
Led by a team with complementary expertise, our sherpa-auditors will guide you to the top by challenging ideas and fostering discussion, ensuring smoother interactions with your Notified Body.
AQUILA®
The eagle’s vision
and precision
for a beneficial audit.
A contradictory audit based on sharing to grow and learn.
But why contradictory? At nexialist, we believe in the power of dialogue and that by challenging and confronting ideas, you will be better prepared for discussions with your Notified Body.
Our team of auditors, certified as IRCA Lead Auditor 13485, supports you across a wide range of technical areas.
Whether it’s internal audits, subcontractor audits, sterilization audits, or mock audits, the strength of our auditors lies in their complementary skills and expertise. This ensures a comprehensive audit, helping you reach the highest standards.
Certified IRCA Auditor 13485
our team
our philosophy
our main
areas of intervention
ISO 13485:2016
Medical Device/IVD Regulations
Process Validation – Sterilization
MDSAP – FDA 21 CFR
Production
Software (SaMD) – AI
Electromedical
Design
Good Manufacturing Practices/GMP/GxP
Cosmetics
christophe
elsa
savéria
laetitia
yani
lucie
The + of nexialist
Types
of audits
internal
audits
The QMS internal audit assesses your organization’s compliance with ISO 13485 and other applicable regulatory and normative frameworks. It identifies gaps, optimizes critical processes such as risk management and traceability, and ensures readiness for external audits.
supplier
audits
The QMS internal audit evaluates your organization’s compliance with ISO 13485 and other applicable regulatory and normative standards. It identifies gaps, optimizes critical processes such as risk management and traceability, and prepares for external audits.
Sterilization
audits
The sterilization audit ensures the compliance of processes with standards and regulations. It verifies controls, traceability, and effectiveness, guaranteeing the safety of sterile medical devices.
mock audit
audits
The mock audit simulates an audit to assess compliance and identify gaps. It effectively prepares teams and processes for official international inspections (FDA, MDSAP, Europe, etc.).