Medical Device Monitoring FDA / MDR Readiness
Contamination Monitoring for Sustained Product Quality
In order to demonstrate that the implemented quality is being maintained, monitoring of the product or components are necessary. The monitoring program is based on the various manufacturing processes and the associated risks of contamination of the product or components. Monitoring ensures that patients, users, and third parties are provided with safely usable medical devices.
Our services include:
I. Basic FDA / MDR Monitoring-Readiness:
✓ Bioburden
- Standards: EN ISO 11737-1, USP (61), EP 2.6.12
Tests: Bioburden Determination, validation of recovery and Germ differentiation (MALDI-TOF)
TAT*: 2-3 weeks
✓ LAL Endotoxin Test
Standards: DIN/TS 5343 (ISO 19227): ISO 11737-3 (ANSI/AAMI ST72, USP (85), EP 2.6.14
TAT*: 2-3 weeks
* estimated turnaround time (TAT) from receipt of the samples at the laboratory depending on medical device category. Individual test results are provided progressively. Additional services such as GLP documentation require one additional week.
II. Optional Tests:
✓ Particle Test
Standards: USP (788) (AAMI TIR42)
TAT*: 2-3 weeks
✓ Cytotoxicity Test
Standards: EN ISO 10993-5, -12
Tests: Cytotoxicity test (BCA/MTT test method)
TAT*: 3-4 weeks
✓ Organic Chemical Analysis
Standards: EN ISO 10993-1, -12, -18
Test: Chemical analysis by TOC/THC (USP (643), ASTM F2847/ ASTM D7066, ASTM F2847)
- TAT*: 3-4 weeks
* estimated turnaround time (TAT) from receipt of the samples at the laboratory depending on medical device category. Individual test results are provided progressively. Additional services such as GLP documentation require one additional week.
