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| Title | CE Marking Approvals (Classifications) | MDR CAN/CSA | 510(k) or Others | (EN) ISO 14971 | (EN) ISO 13485 | Biocomp & Safety Studies Management ISO10993 |
| (Advanced) Wound care products | |||||||||
| Non-wovens/ gauzes | IIa | yes | yes | yes | yes | yes | |||
| Wound dressings for severe and chronic wounds | IIb | yes | yes | yes | yes | ||||
| Hemostats agents | III | yes | yes | yes | yes | ||||
| Medical devices with animal tissue derived components | III | yes | yes | yes | yes | ||||
| Dental products | |||||||||
| Dental implants and accessories | IIa & IIb | yes | yes | yes | yes | ||||
| Tooth whitener | IIa | yes | yes | yes | |||||
| Surgical products and accessories | |||||||||
| Cardiac surgery devices | IIb & III | yes | yes | yes | |||||
| Blood circulation system custom packs | IIa | yes | yes | yes | yes | ||||
| Design and development of (micro mechanical) medical devices | yes | yes | |||||||
| HA-Coated Implants | III | yes | yes | yes | |||||
| Surgical Mesh | IIb | yes | yes | yes | yes | ||||
| Contraceptive products | |||||||||
| Intra uterine devices | III | yes | yes | yes | yes | ||||
| Contraceptive products | IIb | yes | yes | yes | |||||
| Combination products (borderline) | |||||||||
| Heparin coated products | yes | yes | yes | ||||||
| Preventive / Treatment supporting products | |||||||||
| Blood measurement and beat to beat haemodynamic monitoring systems | IIa | yes | yes | yes | yes | yes | |||
| Anti-decubitus mattresses and cushions | I | yes | yes | ||||||
| Training & courses | |||||||||
| Half a day / introductory | yes | yes | yes | yes | yes* | yes | |||
| One day courses | yes | yes | yes | yes | yes * | yes | |||
| One day courses + QSR | yes | ||||||||
| Two day extensive training | yes | >> | >> | yes | yes * | ||||
| In-house training | yes | yes | yes | yes | yes | yes | |||
| * in cooperation with the Dutch Standardization Institute | |||||||||
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Qserve Consultancy
NL-1441 RS, Purmerend The Netherlands T: +31 (0)299 41 2000 |
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