Advena
Advena Ltd is a company dedicated to helping clients navigate the complexities of medical device and cosmetic regulation. With over 25 years of experience, they provide regulatory consulting, QMS expertise, and training, supporting clients in achieving compliance across UK, EU, and international markets. They are BSI-certified for ISO 13485:2016 and offer a wide range of services including medical device regulation, UK Responsible Person services, quality management, auditing, and more. Their team comprises experienced professionals in regulatory and quality consultancy, clinical writing, and compliance, committed to delivering tailored solutions and excellent customer support.
Industries
Nr. of Employees
small (1-50)
Advena
Warwick, Warwickshire, United Kingdom, Europe
Products
Electronic quality management system software
An electronic quality management system offering modules for CAPA tracking, supplier evaluation, document management, change control and related QMS processes to support ISO 13485 compliance.
Electronic quality management system software
An electronic quality management system offering modules for CAPA tracking, supplier evaluation, document management, change control and related QMS processes to support ISO 13485 compliance.
Services
Regulatory strategy, conformity and market entry support for medical device manufacturers and suppliers.
Acting as UK Responsible Person for manufacturers outside the UK to enable placement of devices and cosmetics on the GB market.
Provision of Responsible Person services to meet cosmetic product regulatory obligations for UK and EU markets.
Design and implementation of QMS aligned to ISO 13485:2016 including documentation, processes and audit readiness.
Internal auditing services and facilitation of the Medical Device Single Audit Program to assess and demonstrate QMS compliance.
Regulatory support specifically for in‑vitro diagnostic devices, including IVDR preparedness and submissions.
Regulatory strategy, conformity and market entry support for medical device manufacturers and suppliers.
Acting as UK Responsible Person for manufacturers outside the UK to enable placement of devices and cosmetics on the GB market.
Provision of Responsible Person services to meet cosmetic product regulatory obligations for UK and EU markets.
Design and implementation of QMS aligned to ISO 13485:2016 including documentation, processes and audit readiness.
Internal auditing services and facilitation of the Medical Device Single Audit Program to assess and demonstrate QMS compliance.
Regulatory support specifically for in‑vitro diagnostic devices, including IVDR preparedness and submissions.
Expertise Areas
- Medical device regulatory compliance
- In‑vitro diagnostic regulation (IVDR/IVD)
- Quality management systems and ISO 13485 compliance
- Regulatory representation (UK Responsible Person, EU Authorised Representative)
Key Technologies
- Electronic quality management systems (eQMS)
- Document management and change control workflows
- CAPA management systems
- Supplier evaluation workflows