AlvaMed

Alva Med

Other, 1116 Great PLN Ave, Needham, Massachusetts, 02492, United States, 11-50 Employees

alvamed.com

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phone no Phone Number: +17*********

Who is ALVAMED

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, regu...

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  • 1116 Great PLN Ave, Needham, Massachusetts, 02492, United States Headquarters: 1116 Great PLN Ave, Needham, Massachusetts, 02492, United States
  • 2002 Date Founded: 2002
  • 11-50 Employees: 11-50
  • dollar-icon Revenue: $5 Million to $10 Million
  • tech-icon Active Tech Stack: See technologies

industries-icon Industry: Other

SIC SIC Code: 8742 | NAICS Code: 541611 | Show More

checked-icon Does something look wrong? Fix it. | View contact records from ALVAMED

AlvaMed Org Chart and Mapping

Employees

Jon Saltonstall

Vice President, Regulatory and Quality Compliance

Amelia Mottet

Associate Quality Compliance Consultant

John Nagle

Senior Quality Assurance Consultant

CCRP Kerry Beckett

Medical Device Consultant | Clinical Affairs | Regulatory Affairs | Quality Systems

Chelsae O'Halloran

Quality Compliance Consultant

Brian Ludovico

Director of Quality Affairs

Marcia Kelley

Documentation Specialist

Melissa Hooper

Quality Assurance Specialist

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Frequently Asked Questions Regarding AlvaMed

Answer: AlvaMed's headquarters are located at 1116 Great PLN Ave, Needham, Massachusetts, 02492, United States

Answer: AlvaMed's phone number is +17*********

Answer: AlvaMed's official website is https://alvamed.com

Answer: AlvaMed's revenue is $5 Million to $10 Million

Answer: AlvaMed's SIC: 8742

Answer: AlvaMed's NAICS: 541611

Answer: AlvaMed has 11-50 employees

Answer: AlvaMed is in Other

Answer: AlvaMed contact info: Phone number: +17********* Website: https://alvamed.com

Answer: 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.

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