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Richard Young joins the Mediqol team

posted by Colin Rylett

Monday, June 1, 2009

I’m delighted to be able to announce that Richard Young will shortly be joining the Mediqol team.

Richard joins us from Renishaw Neurological Products and has MDD, AIMDD and IVD experience in Europe, the USA and some ROW markets. Richard has over 15 years medical devices experience with companies such as Zimmer, Alaris Medical and Plasma Surgical and we are very much looking forward to letting him utilise this experience with our clients.

Regulatory
- CE Marking
- Design Dossier, Technical File and Design History File Compilations
- Reimbursement Consultancy
- FDA Submissions
- Worldwide Regulatory Submissions
Clinical
- Clinical Trials Management
- Monitoring
- Protocols, Investigator Brochures and Ethics Committee Submissions
- Post-Marketing Surveillance
Scientific and Technical
- Project Planning and Implementation
- Interim Management
- Due Diligence
- Technology Valuation
Quality
- Drafting and Implementation of ISO and FDA Compliant Systems
- GAP Analyses
- Pre-assessment Auditing
European Authorised Representative
- 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)
Validation
- Validation Plans
- Validation Protocols and Reports
- Validation Strategies
- Validation Policies and Procedures
Reimbursement
- Reimbursement strategies and applications
- Health economics
Training
- Tailor made training courses for individual clients
- Regular training courses held for the medical device community