ISO Sense
ISO Sense specializes in quality management and regulatory compliance for the Life Sciences sector, including in-vitro diagnostics, medical devices, and laboratory testing. They provide tailored solutions to help clients navigate complex regulations, ensuring regulatory excellence and aligning compliance with business objectives.
Industries
Nr. of Employees
small (1-50)
ISO Sense
Manchester, Manchester, United Kingdom, Europe
Services
End‑to‑end support to plan and implement initial certification and readiness activities for regulated products and management systems.
Audits of quality and management systems and delivery of gap analysis reports to identify nonconformities and remediation actions.
Training programmes focused on regulatory requirements and quality management system implementation to build internal competence.
Design and implementation of integrated management systems to consolidate compliance and business processes.
Investigative and remedial support to resolve compliance issues and address regulatory challenges.
Specialist regulatory consulting focused on compliance requirements for medical devices and in‑vitro diagnostics.
End‑to‑end support to plan and implement initial certification and readiness activities for regulated products and management systems.
Audits of quality and management systems and delivery of gap analysis reports to identify nonconformities and remediation actions.
Training programmes focused on regulatory requirements and quality management system implementation to build internal competence.
Design and implementation of integrated management systems to consolidate compliance and business processes.
Investigative and remedial support to resolve compliance issues and address regulatory challenges.
Specialist regulatory consulting focused on compliance requirements for medical devices and in‑vitro diagnostics.
Expertise Areas
- Regulatory compliance for life sciences
- Quality management systems implementation
- In‑vitro diagnostics (IVD) compliance
- Medical device compliance
Key Technologies
- Quality management system implementation (ISO standards and equivalents)
- Audit methodologies for management systems
- Regulatory strategy and interpretation for medical devices and IVDs
- Integrated management system design