SEL-Innovation
Consultancy focused on design, implementation and continuous optimisation of management systems (quality, environment, workplace) for medical device, manufacturing and service sectors. Provides support for certification readiness, regulatory compliance for medical devices, audit services, project management and data-driven management reporting. Services are offered internationally through a global network.
Industries
Nr. of Employees
small (1-50)
SEL-Innovation
Products
Management Consulting Services
Consulting services focused on optimizing business processes and adapting to market changes to improve resource utilization.
Medical Device Consulting Services
Consulting services that support companies in the medical device sector with regulatory, development, and market adaptation challenges.
Management Consulting Services
Consulting services focused on optimizing business processes and adapting to market changes to improve resource utilization.
Medical Device Consulting Services
Consulting services that support companies in the medical device sector with regulatory, development, and market adaptation challenges.
Services
Management system consulting
Consulting for structuring, implementing and optimising management systems covering quality, environment and workplace safety.
Certification and regulatory compliance support
Support and preparation for ISO and sector certifications and compliance with medical device directives and CE marking requirements.
Auditing services
Execution and support of internal audits and second- and third-party audits for management systems.
Project management and due diligence
Project management for implementation projects and provision of tools for due diligence assessments.
Management system consulting
Consulting for structuring, implementing and optimising management systems covering quality, environment and workplace safety.
Certification and regulatory compliance support
Support and preparation for ISO and sector certifications and compliance with medical device directives and CE marking requirements.
Auditing services
Execution and support of internal audits and second- and third-party audits for management systems.
Project management and due diligence
Project management for implementation projects and provision of tools for due diligence assessments.
Expertise Areas
- Management system optimisation
- Quality management systems (QMS)
- Medical device regulatory compliance and CE marking
- ISO certification readiness
Key Technologies
- ISO standards implementation
- European Medical Device Directives (CE marking)
- Auditing methodologies (internal/2nd/3rd party)
- Management systems design and integration