Medical Device & Diagnostics Regulatory Affairs
- Regulatory strategy development and pathways to market
- Consultancy services and support throughout the product life cycle
- Device classification determination, intended use statement development and predicate device determination
- Pre-market, post-approval and post-market support
- Appraisal and evaluation of technical documentation
- Preliminary assessments, gap analyses and desktop audits
- Technical files, design dossiers and quality system support
- European authorized representation services and UK responsible person services
- Notified Body discussions and pre-submission FDA meetings