ISO 13485:2003 Certified Quality Management System
Bioretec meets the requirements of:
- European Medical Device Directive (MDD) 93/42/EEC as last amended by Directive 2007/47/EC
- ISO 13485:2003 “Medical devices – Quality management systems – Requirements for regulatory purposes”
- Code of Federal Regulations (CFR) Title 21 Part 820 “Quality System Regulation” (QSR)
- The additional national requirements of each country, where we are selling products
By conforming with the above international and national quality and regulatory requirements and quantity of harmonized standards we are able to provide our customers with medical products, which improve healing and the quality of life. Our Quality Management System is targeted to support us to continuously assess and improve our performance in all our operations for the satisfaction of our customers, partners, staff and owners.
Our goal is to develop and manufacture unique, high-quality bioabsorbable, bioactive and drug-releasing surgical implants for musculoskeletal applications.
Product clearances
The Bioretec products have been cleared by US FDA and the CE mark has been granted by KEMA. In addition, the products have been cleared for sales in several other countries worldwide.
Membership
Bioretec is a member of The Finnish Healthcare Technology Association (FiHTA).
Downloads
| Filename | Description | |
|---|---|---|
 |
CE_Marking_of_Conformity_and_Addendum.pdf | CE Marking of Conformity and Addendum |
| |
Certificate_Bioretec_pin_product_group.pdf | Certificate_Bioretec pin product group |
| |
Certificate_Bioretec_screw_product_group.pdf | Certificate_Bioretec screw product group |
| |
ISO13485_Certificate_No_2086412.pdf | ISO13485 Certificate No 2086412 |