Neovasc is committed to developing, manufacturing and marketing vascular
and surgical devices of the highest quality. A wide range of medical device products are approved for sale in the U.S, Europe, Canada and elsewhere that were developed by Neovasc and are manufactured at our facility, or which incorporate our pericardial tissue. We are
regulated by the US-FDA, Health Canada and European notified bodies and follow all applicable standards and guidelines. We have an established and tested Quality Management System that is audited annually by
our notified body ( BSI) and were recently US-FDA audited without a single deficiency.
Tissue Certifications
- ISO 13485:2003 (CMDCAS) (375KB PDF)
- Health Canada Medical Device Licence (238KB PDF)
- EC Directive 93/42/EEC Annex II, Article 3 (973KB PDF)
- EC Directive 93/42/EEC Annex II, Article 4 (837KB PDF)
- EDQM Certificate of Suitability (972KB PDF)
Additional Product Certifications
- ISO 13485:2003 (CMDCAS) (375KB PDF)
- Health Canada Medical Device Licence (128KB PDF)
US-FDA Certifications
Click here for a complete list of our US-FDA approved products.
