Regulatory Strategy

ClinChoice strategists help medical device innovators enter new markets and maintain their registration statuses in existing markets with a deep understanding of complex regulations, knowledge of product-specific nuances, and engagement with health authorities.

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