project portfolio
| Title | CE Marking Approvals | MDR CAN/CSA | 510(k) or Others | (EN) ISO 14971 | (EN) ISO 13485 | ISO10993 | (EN) ISO 14155 |
|---|---|---|---|---|---|---|---|
| Advanced Wound care products | |||||||
| Creams, lotions, non- wovens / gauzes | II a | yes | yes | yes | yes | yes | yes |
| Wound dressings for severe and chronic wounds, bioresorbables | II b | yes | yes | yes | yes | yes | yes |
| Hemostats (inclusive animal origin) | III | yes | yes | yes | yes | yes | yes |
| Sutures | III | no | yes | yes | yes | yes | no |
| Dental products | |||||||
| Dental implants and accessories | II a | yes | yes | yes | yes | yes | no |
| Dental resins | II a | no | no | yes | yes | yes | yes |
| Tooth whitener | II a | yes | no | yes | yes | no | no |
| Opthalmic | |||||||
| Liquids, gels | II a & ll b | no | no | yes | yes | yes | yes |
| Surgical products and accessories | |||||||
| Cardiac surgery devices | II b & III | no | yes | yes | yes | no | no |
| Blood circulation system custom packs | II a | no | yes | yes | yes | yes | no |
| Design and development of (micro mechanical) medical devices HA-coated Implants | III | no | no | yes | yes | yes | no |
| Percutaneous transluminal surgical applications (delivery systems & implants) | II b & III | yes | no | yes | yes | yes | yes |
| Surgical Mesh | II b | yes | no | yes | yes | yes | no |
| Contraceptive Devices | |||||||
| Intra uterine devices | III | yes | yes | yes | yes | yes | yes |
| Contraceptive products | II b | no | yes | yes | yes | yes | yes |
| Combination products (borderline) | |||||||
| Heparin coated products | III | no | no | no | yes | yes | no |
| DES (Drug eluding stents) and other coated stents (inclusive animal tissue) | III | yes | yes | yes | yes | yes | yes |
| Organ preservation fluid | no | no | yes | yes | yes | yes | |
| Diagnostic/Other | |||||||
| Blood measurement and beat tot beat haemodynamic monitoring systems | II a | yes | yes | yes | yes | yes | no |
| Imaging devices | I & II a | no | yes | yes | yes | yes | yes |
| Anti-decubitus mattrasses and cushions | I | no | no | yes | yes | no | no |
| Donor organ transportation system | II a | no | no | yes | yes | no | no |
| Biomaterials (such resorble, drug release, wound dressing, dental) | IIb and III | no | yes | yes | yes | yes | yes |
| Software | |||||||
| Imaging software | II a | no | no | yes | yes | yes | yes |
Please note this list is not exhaustive, Qserve have also consulted on active implantables, devices for plastic surgery, microbial devices, etc. Contact Qserve to discuss your particular requirements………