We offer targeted Consulting Services powered by the unique capabilities of our international team. We match your project to a subject matter expert with clinical experience in the field of your device, offering unparalleled clinical evidence generation, identification, appraisal & analysis. Our core services include:
- Clinical Evaluation Complete CER & CEP writing service
- Literature Search & Review Search protocols & SOTA reviews
- Post-Market Clinical Follow-up PMCF Study design & management
- Summary of Safety and Clinical Performance SSCP writing & readability testing
If you'd prefer to manage your regulatory processes in-house, our EnableCE Toolkit offers a range of digital products and services to support market access for your devices: