Comprehensive and stress-free computerised system validation services tailored for the MedTech industry
EUMEDIQ offers comprehensive computerised system validation services for small and medium-sized enterprises and manufacturers in the MedTech industry that lack dedicated IT or quality assurance expertise, combining deep knowledge of IT management and quality assurance.
WHAT WE DO
CSV is a regulatory requirement; we make managing it straightforward
Computerised System Validation is a regulatory requirement outlined in ISO 13485, ensuring that computerised systems in regulated environments operate securely and effectively. Since 2016, Notified Bodies and regulatory authorities have expected seamless validation and audit readiness across all computerised systems. EUMEDIQ takes full responsibility for CSV requirements and maintenance, freeing up internal resources and eliminating the need to hire expensive CSV-trained additional staff.
2016
Since 2016, Notified Bodies and regulatory authorities have expected seamless validation and audit readiness across all computerised systems.
ISO 13485
CSV is a regulatory requirement under ISO 13485, applicable to all computerised systems used in regulated medical device environments.
24/7
Your IT environment remains audit-ready at all times, with continuous monitoring and automatic validation of all software changes.
CORE COMPETENCIES
Comprehensive CSV services covering every aspect of validation and audit readiness
EUMEDIQ's CSV services cover the full scope of validation requirements, from risk assessment and software validation through to continuous monitoring, repository solutions, and ongoing audit readiness. Our cloud-based CSV portal ensures seamless collaboration between you, your IT partner, and EUMEDIQ, with a centralised overview of all software and hardware components giving defined parties full transparency and access at all times.
We address the challenges manufacturers most commonly face, including maintaining validation status during software updates, eQMS platform compliance, document management system validation, and ensuring widely used software such as Adobe Acrobat remains aligned with regulatory standards. If you or your IT service partner uses Microsoft Intune for device endpoint management, we can tailor our service accordingly.
Audit readiness
Your IT environment remains audit-ready at all times, freeing up internal resources and eliminating the need for dedicated in-house CSV expertise within your organisation.
Scalable solutions
From basic documentation to comprehensive validation, we provide flexible and customisable service packages tailored to the specific needs and size of your organisation.
Repository solutions
Our cloud-based CSV platform provides a centralised overview of all software, hardware, and spreadsheet components, with full transparency and access for defined parties at all times.
Continuous monitoring
We continuously monitor software changes made by manufacturers or operating systems and validate them automatically to maintain compliance at all times.
Software validation
Ensuring your software meets all regulatory requirements and validating changes efficiently, including spreadsheet validation and document management systems.
Risk assessment and approval
Every new computerised system undergoes a thorough risk assessment and documented approval process before deployment in the regulated environment.
WHO BENEFITS
Designed for manufacturers in regulated industries without dedicated in-house CSV expertise
EUMEDIQ's CSV services are designed for small and medium-sized MedTech companies without in-house CSV or IT expertise, manufacturers seeking to ensure audit readiness and seamless validation across software and computerised systems, and companies in regulated industries requiring GxP compliance. We address the most common validation challenges, including maintaining validation status during software updates, conducting risk assessments and revalidations for system changes, and ensuring operational continuity is not disrupted by IT changes.
Compliance
Seeking to ensure audit readiness and seamless validation regarding software and computerised systems at all times.
SME
Small and medium-sized MedTech companies without in-house CSV or IT expertise, requiring reliable and scalable validation solutions.
GxP
Regulated industry companies requiring GxP compliance across computerised systems and IT environments in regulated industries.