0
Active Certifications
↑ 12% YoY
0
Audit Compliance
Stable
0
Non-Conformities (36mo)
✓ Zero Tolerance
ISO
9001/14001/45001
Integrated QMS
Core Quality & Safety
ISO 9001:2015
Active
BSI Group · United Kingdom
Quality Management Systems for nanomaterial synthesis, microfabrication processes, and cleanroom manufacturing operations.
ISO 14001:2015
Active
DNV · Norway
Environmental Management covering solvent recovery, nanoparticle waste stream handling, and facility emissions control.
ISO 45001:2018
Active
Bureau Veritas · France
Occupational Health & Safety for high-risk nanomanufacturing, chemical handling, and cleanroom personnel protocols.
Regulatory & Industry Specific
FDA 510(k) Cleared
Active
U.S. Food & Drug Administration
Class II nanomedical devices including targeted drug delivery carriers and biosensor diagnostic platforms.
CE Marking (MDR 2017/745)
Active
TÜV Rheinland · Germany
European medical device regulation compliance for nanostructured implants and point-of-care testing kits.
REACH Compliant
Perpetual
European Chemicals Agency (ECHA)
Full registration, evaluation, and restriction of chemicals used in nanoparticle production and coating formulations.
SEMI S2/S8
Active
SEMI Alliance · International
Semiconductor manufacturing facility safety standards covering electrical, chemical, and gas safety in cleanroom environments.
Regional Compliance Matrix
| Region | Regulatory Body | Standard | Status |
|---|---|---|---|
| North America | FDA / OSHA / EPA | 21 CFR Part 820, GMP, TSCA | Compliant |
| European Union | ECHA / MDR / CLP | REACH, ISO 13485, CE Mark | Compliant |
| Asia Pacific | NMPA (CN) / PMDA (JP) / TGA (AU) | NMPA Class III, JPAL, GTP | Pending Renewal |
| Middle East | SAFDA (KSA) / MOHAP (UAE) | GSO Standards, CE Alignment | Certified |