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MedTech Review, LLC - Regulatory Submission, Quality System Compliance, Quality Assurance
Establish web-based Quality Management Systems (QMS) Part 11 compliant. 21 CFR 820 QSR audits, Mock FDA audits, GAP Analysis, Quality Planning (ISO 10005). Corrective and Preventive Actions; Managing closure of US FDA Warning Letters. 510(k) and de novo submissions. Electronic MDR Agent (21 CFR 803). CMDCAS, ISO 13485, CE Marking certifications. EU Tech Files, Risk Management Files (ISO 14971), Usability Engineering Files (IEC 62366), Software (IEC 62304). We’re here when you need us. And keep them there.
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