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Alvamed Inc.

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AlvaMed is a consulting firm to the medical device industry. We offer a comprehensive suite of compliance services to our clients, covering quality assurance, quality system development, regulatory approval and compliance, as well as CRO/clinical management services. AlvaMed is an industry leader in medical device consulting and is comprised of technically savvy quality, clinical and regulatory professionals with a broad range of complementary skills. US FDA submissions; CE Marking and Technical File updates with EU notified bodies; ISO 13485, MDSAP and other certification assistance; Audits; Due diligence support. Quality system development, documentation and remediation; Product labeling and documentation support; Unique Device Identifier (UDI) support; IEC 60601 support; Audit response, clinical evaluation reporting, complaints and CAPA remediation; Clinical trial protocol creation, study oversight, site initiation, CRA management, closeout and reporting; Postmarket surveillance system assessment and strategy.

Company Details

Address
1116 Great Plain Ave
Needham, MA 02492

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Categories

Med Device Med Rect 4.30.26
MedDevice_3:1_8.1.20
Med Device