Standards
ISO
- 7206
- 8827
- 11491
- 14242
- 14879
- 15142
- 18192
- 22622
- 23089
ASTM
- F382
- F384
- F543
- F564
- F1223
- F1264
- F1357
- F1378
- F1541
- F1714
- F1717
- F1781
- F1798
- F1800
- F1814
- F1820
- F1829
- F1875
- F2009
- F2028
- F2077
- F2180
- F2193
- F2267
- F2345
- F2346
- F2423
- F2502
Services
Section 7 Testing has over 30 years of experience generating reports that sail through regulatory agencies such as the USFDA. Standards testing, custom testing, and advanced computational product development are our specialties.
Custom
- Regulatory deficiency letters
- Small joints
- Fixation
Computational
- Virtual F1223
- KneeSIM range of motion
- Contact area and stress
Anatomy Bundles
Most clients need a battery of tests to clear a single implant. S7T offers bundle pricing on combined mechanical, wear, and computational programs by anatomy.
- Knee
- Hip
- Spine
- Shoulder
- Ankle
Why S7T
- Predicate data. 25+ years of performance data on cleared devices — the comparison datasets your 510(k) needs.
- FDA-accepted methods. Including the ORL-developed virtual ASTM F1223-14 protocol accepted in a 510(k) submission.
- Standards authorship. Direct lineage from a lab that helped write the standards regulatory bodies use.
- One vendor, three disciplines. Mechanical bench, wear simulators, and computational models in-house.