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Comprehensive Regulatory Strategy Solutions
- Strategy setup from the start of product development
- Market selection for first-launch based on regulatory complexity
- Recommendations for implementation of best practices that can be replicated to accelerate product registration in other markets
- Level of evidence needed based on the target market
- Competitive landscape and target market assessments to identify reasons for successes or complications
- Gap identification and providing a regulatory pathway to meet global or local product registration and maintenance requirements
- Documentation reviews for new and existing products including but not limited to:
- Device classification
- Predicate device
- Performance tests
- Pre-clinical data
- Clinical evidence
- Labeling claims
- Supporting literature
- Intended uses and clinical applications
- Evaluate existing technical files, design dossiers, clinical evidence (CERs), and quality management systems (QMS) to ascertain compliance with EU MDR and develop remedial plans as needed
