We are excited to announce the launch of Nextern Consulting Services, a dedicated consulting practice designed to help medical device companies navigate complex regulatory, clinical, quality, and product lifecycle challenges.
Nextern Consulting Services supports customers across the full product lifecycle, from early regulatory strategies and quality system development to market access, product stewardship, and commercialization.
“Medical device companies are being asked to move faster while meeting increasingly complex regulatory, clinical, and quality expectations. Nextern Consulting Services was built to give teams the specialized support and execution discipline they need, whether they are preparing for FDA submission, building or strengthening a quality system, or navigating EU MDR requirements.” — Caroline Byrd, Vice President of Regulatory, Clinical and Quality, Nextern
What sets the services apart is their connection to Nextern’s broader operating environment. Consulting clients can draw on Nextern’s experience in product development, manufacturing, quality systems, and commercialization — including its bio-simulation lab in Maple Grove, Minnesota, and operations across five global sites spanning the United States, Costa Rica, Vietnam, and China. This integrated model gives customers a consulting and ongoing services partner grounded in real-world device execution.
These new services also support companies navigating EU MDR and IVDR requirements, including technical documentation, Clinical Evaluation Reports, Person Responsible for Regulatory Compliance (PRRC) support, and European market access planning. For non-EU manufacturers, Nextern can help define the regulatory infrastructure and partner model required for market entry and ongoing compliance.
Nextern Consulting Services further addresses growing demand for Software as a Medical Device, digital health, and cybersecurity expertise — including AI and machine learning regulatory strategy, Predetermined Change Control Plan (PCCP) planning, SaMD compliance strategy, IEC 62304-aligned software lifecycle support, and cybersecurity program planning for connected devices.
“This launch reflects how we define partnership at Nextern. Across the entire product lifecycle, our role is to offer a full range of solutions, solve complex challenges, and help move meaningful medical technologies forward with quality and velocity.” — John Hastings, Chief Executive Officer, Nextern
Nextern Consulting Services is available now to companies seeking targeted advisory support, added execution capacity, or a fully integrated partner.
Who Nextern Consulting Services Supports
Startup founders: Regulatory pathway design, FDA Q-Sub and submission planning, quality system buildout, sterilization strategy, and early EU market entry strategy.
Regulatory and quality leaders: Strategy for global submissions, risk management, verification and validation, remediation planning and execution, PLM strategy and deployment, simplification of complex portfolios, and quality system execution.
Companies entering or maintaining EU market access: EU MDR technical documentation, Clinical Evaluation Reports, PRRC support, and European regulatory planning for non-EU manufacturers.
ABOUT NEXTERN
Nextern is Medical Device, Enabled. Across the entire product lifecycle, Nextern partners to solve patient needs and improve lives. From early concept through commercialization, Nextern enables medical device companies through integrated product development, manufacturing, quality, regulatory, clinical, and consulting capabilities. Nextern operates across five global sites spanning the United States, Costa Rica, Vietnam, and China.
Learn more at nextern.com.