NSF International, a provider of regulatory compliance, quality systems, analytical testing, education and consulting services for the medical device sector, has acquired Avarent LLC, a consulting firm with expertise in medical device products and processes development, design control, validation, quality assurance and regulatory compliance. Avarent will be renamed NSF Avarent.
The addition of Avarent expands NSF International’s portfolio of medical device services to both NSF International and Avarent clients, combining Avarent’s expertise with NSF International’s experience in regulatory compliance and quality management systems throughout the medical device product lifecycle.
The acquisition was made through NSF International’s Global Health Sciences Division, and builds on NSF’s 2012 acquisition of Washington D.C.-based regulatory compliance consulting firm Becker & Associates and UK-based medical device training and consulting firm Pink Associates, as well as NSF’s 2011 acquisition of Pharmalytica, a GLP and GMP contract laboratory.
Benefits of acquisition to NSF medical device clients
As a result of the acquisition, current clients of NSF Medical Device Consulting will gain access to world-class expertise in device products and processes, design control and validation that will help them implement efficient, streamlined and cost-effective manufacturing processes while achieving optimal quality and regulatory compliance. This includes a global network of 80 expert consultants with experience in U.S. Food and Drug Administration, International Standardization Organization , Good Automated Manufacturing Practice, Health Insurance Portability and Accountability Act and Sarbanes-Oxley standards and regulations.
Services offered through the Avarent acquisition include:
- Product and process development, delivery and commercialization – Avarent helps improve and manage development processes and technologies that support and simplify medical device manufacturing and commercial operations. This includes assistance in design and development planning, design review and design transfer, and process analysis to identify, plan and enact improvements and determine the best approach for project delivery and optimized return on investment.
- 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 and technical files and unique device identifier (UDI) submissions.
- 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 and GUDID requirements for approximately 2,000 regulated U.S. medical devices across various facilities.
- Quality management system development – Avarent helps companies establish and maintain tailored quality systems, including compliance with ISO 13485, U.S. FDA Quality System Regulation and other global quality requirements.
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.
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.
“NSF International and Avarent share the same commitment to delivering smart solutions focused first on patient safety and regulatory compliance. By combining our expertise, Avarent and NSF clients will have access to leading edge consultants dedicated to optimizing medical device design and manufacturing while mitigating risk and ensuring quality and regulatory compliance throughout the product lifecycle,” said Ian Fleming, executive VP of NSF Avarent, now part of NSF Medical Device Consulting under NSF International’s Global Health Sciences Division.
Additionally, Avarent clients will gain access to other NSF capabilities:
- Global client support in more than 160 countries, including across Asia, the Middle East, Africa, Europe and Central and Latin America
- A global network of ISO 17025-accredited laboratories in Europe, Asia, North and South America
- Global IT infrastructure with key tools to aid client engagement
Avarent was founded in 2003 by Fleming, with Thomas Dzierozynski joining in 2006. Both Fleming and Dzierozynski will join NSF International as executive VPs, reporting to Elaine Messa, president of NSF Health Sciences Medical Device Consulting, and will lead the integration of Avarent services into NSF Medical Device Consulting.
“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.”
“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 Dzierozynski, executive VP of NSF Avarent.
NSF Medical Device Consulting