Medical devices
Medical devices — registration, post-market and clinical evidence
We handle compliance for medical and dental devices — from risk-class classification and software as a medical device (SaMD) to post-market changes — and support clinical evidence with systematic literature review, meta-analysis and incorporation into the CER.
What we deliver
- Risk-class classification and submission strategy
- Dossier structuring and electronic submission
- Systematic literature review and meta-analysis for clinical evidence
- Handling of post-market changes until publication in the DOU
Who it's for
Domestic and international manufacturers, importers and startups of health products, including software.
Documents we usually request
- Technical documentation and classification report
- Labeling and instructions for use
- Available clinical and safety data
Not included
- Anvisa fee
- Translation beyond English and Spanish
- Appeal against rejection