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FDA Approves Element as ASCA-Recognized Laboratory Element Materials Technology (Element) has received approval to take part in the FDA’s Accreditation Scheme for Conformity Assessment (ASCA) pilot program for medical device testing. The ASCA program provides accredited, independent testing laboratories with the approval to assess medical devices for compliance with FDA-recognized standards, facilitating a more efficient review process and faster market access. Element will perform electromagnetic compatibility (EMC) and wireless coexistence testing from five strategically positioned laboratories across the US. Element’s accreditation covers all medical products governed by FDA regulations. The ASCA program provides manufacturers with an opportunity to get to market quicker. The FDA assumes a level of trust for the testing laboratory and aside from regular quality audits, test results will not require further review to receive FDA approval, saving significant time in the proc

United statesUnited kingdomSouth koreaSteve hayesElement materials technologyFrom element materials technologyaprMaterials technologyConformity assessmentTechnical directorConnected technologiesஒன்றுபட்டது மாநிலங்களில்ஒன்றுபட்டது கிஂக்டம்தெற்கு கொரியாஸ்டீவ் வைக்கோல்உறுப்பு பொருட்கள் தொழில்நுட்பம்பொருட்கள் தொழில்நுட்பம்