Services
The UK office of Emergo Group (formerly Mediqol) assists companies at every stage throughout the life-cycle of a medical product from the early stages of design and development, to assessing the regulatory pathway, clinical trials, the implementation of an appropriate quality system and beyond – to product approvals, reimbursement and post-market surveillance.
The menu on the left will take you to pages which describe in a little more detail some of the services we offer which include, but aren’t limited to:
Regulatory
- CE Marking
- Design Dossier, Technical File and Design History File Compilations
- FDA Submissions
- Worldwide Regulatory Submissions
Clinical
- Clinical Trials Management
- Monitoring
- Protocols, Investigator Brochures and Ethics Committee Submissions
- Post-Marketing Surveillance
Quality Assurance
- Drafting and Implementation of ISO and FDA Compliant Systems
- GAP Analyses
- Internal and Supplier Audits
- Pre-assessment Auditing
Scientific and Technical
- Project Planning and Implementation
- Interim Management
- Due Diligence
- Technology Valuation
Validation
- Validation Plans
- Validation Protocols and Reports
- Validation Strategies
- Validation Policies and Procedures
European Union Authorized Representation
- Established business with permanently manned offices
- Able to offer additional services to EUAR clients
- Within team have multiple language capability (English, German, Dutch, French, Spanish, Italian, Russian and more)
Reimbursement
- Reimbursement strategies and applications
- Health economics
Training
- Tailor made training courses for individual clients
- Regular training courses held for the medical device community
To see a complete overview of services offered by Emergo Group, please visit the EmergoGroup.com website.
