AlvaMed, Inc.
Abbie Banjak Merson is an accomplished finance professional with extensive experience in accounting and office management. Currently serving as the Accounting & Office Manager at AlvaMed, Inc. since July 2022, Abbie previously held various leadership positions at The PostureWorks, including Senior Bookkeeper and Director of Financial Operations, where oversight of accounting operations and staff development was emphasized. Abbie also operated Abbie's Bookkeeping, managing multiple clients' financial needs, and held various roles at CSC - Computer Sciences Corporation, focusing on accounting systems management and business analysis. Abbie's early career includes positions at Union Wadding Company and participation on its Board of Directors. Abbie holds a Bachelor’s degree in Business Administration from Babson College and an MBA from Simmons University.
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AlvaMed, Inc.
AlvaMed is a medical device consulting and outsourcing organization. We provide the full breadth of compliance services to our clients: quality assurance, quality system development, regulatory approval and compliance, and 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. The flexibility within our team allows us to quickly adapt our level of support to your changing needs or shift focus as you hire your own internal resources. We strive to build long term relationships with our clients by listening to them and then providing “right sized” services and solutions. Regulatory, clinical and quality compliance consulting services to the lifescience industry, including: * 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.