AlvaMed, Inc. Logo - medical devices

AlvaMed, Inc.

medical devices
China's Best One-Stop Medical Equipment Provider
About

AlvaMed, Inc. is a consulting firm established in 2002, based in Needham, Massachusetts. The company specializes in providing expert services to the medical device industry throughout the entire product lifecycle. Their team consists of professionals with expertise in science, engineering, clinical affairs, quality assurance, and regulatory compliance. AlvaMed offers a wide range of services to assist medical device companies in achieving regulatory approval and maintaining compliance. Their core offerings include regulatory consulting, quality system development, clinical trial management, and postmarket surveillance. They also provide support for product labeling, Unique Device Identifier (UDI) compliance, and due diligence. AlvaMed tailors its solutions to meet the specific needs of each client, serving as a flexible outsourcing partner for regulatory, quality, and clinical affairs. Their expertise spans multiple regions, allowing them to support a diverse clientele from startups to established firms in the medical device sector.

Technologies
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Keywords
regulatory affairs quality systems clinical trials medical device combination product 510 qsub pma ide technical file ce mark quality management system cro clinical affairs postmarket surveillance document control udi consulting regulatory compliance regulatory training clinical data management technical file remediation de novo submissions remediation services medical devices clinical affairs due diligence mdsap mock audit fda warning letter clinical site management clinical evaluation reports
Company Information
  • Employees 18
  • Founded 2002
  • Annual Revenue $15009000
Location

1116 Great Plain Ave, Needham, Massachusetts, United States, 02492

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