NSF International Strengthens Medical Device Consulting With Acquisition of Avarent LLC
The addition of Avarent expands
The acquisition was made through
Benefit of acquisition to NSF medical device clients. As a result of the acquisition, current clients of
Services offered via the Avarent acquisition include:
Regulatory Submissions - As part of the development process, Avarent ensures requirements for regulatory submission are addressed during design and development planning for software, electromechanical and sterile medical device products, including 510(k) premarket, EU medical device directive/technical file and unique device identifier (UDI) submissions.
Unique Device Identifier (UDI) – Regulatory consulting and management of the UDI program includes program management support, labeling change control management, Global Unique Device Identification Database (GUDID) management and master product tracker management. Avarent has implemented UDI/GUDID requirements for approximately 2,000 regulated U.S. medical devices across various facilities.
Commissioning, Qualification and Validation – Avarent helps assess a company's current state of compliance and develop a more robust commissioning, qualification and validation practice to support the operational systems.
Project Management – Avarent's experienced project managers possess expertise in the mechanics of building teams, plans, budgets and schedules for global compliance and regulatory projects that involve multiple cross-functional teams.
Benefit of acquisition to Avarent clients. Avarent clients will gain access to
NSF's current medical device services include quality systems implementation, remediation and auditing services; regulatory and clinical strategy consulting for medical devices including in vitro diagnostics and combination products; clinical and biological evaluations; and GLP and GMP contract laboratory services such as extractables and leachables testing, clinical and non-clinical bioanalysis, oligonucleotide analysis, biocompatibility testing and toxicological risk assessments. NSF's medical device team also provides essential quality and regulatory training courses taught by some of the most experienced professionals in the industry.
Additionally, Avarent clients will gain access to other NSF capabilities:
Global client support in more than 160 countries, including across
A global network of ISO 17025-accredited laboratories in
Global IT infrastructure with key tools to aid client engagement
Avarent was founded in 2003 by
"The addition of Avarent's technical production process and validation services and technical compliance consulting allows us to go beyond traditional consulting services to reduce costs for our medical device customers through improved operational efficiency," said Messa. "Together, we will provide our clients with more comprehensive solutions that ensure the design and manufacture of safer, higher quality medical devices."
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"The client value of our combined organizations extends beyond strategic consultation to offer delivery of optimized solutions that synchronize business goals with compliance needs. We will work together to increase awareness at all levels of an organization to drive client buy-in and ownership of the enacted solutions," said
For more information about
Editor's note: To schedule an interview with an
About Avarent: Avarent was founded in 2003 on the basis that business and compliance are not mutually exclusive goals. Their staff has direct experience in working in operations and compliance to deliver value-based consultancy that includes: Quality System audits, strategic and tactical execution of worldwide quality system and validation projects, project management, technology solutions and regulatory submissions. They are actively involved in assisting regulated clients worldwide in meeting the current regulatory trends specific to quality management systems, risk management, supplier quality, software and process validation, and medical device regulatory submissions. More information on Avarent is available at http://www.avarent.com.
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