Surgical Device Transfer
Achieved a 30% throughput increase and a 30% cycle time reduction following seamless site-to-site contract manufacturing relocation.
Accelerating Medical Device New Product Introduction (NPI) and Legacy Transfers with Uncompromising Quality and Risk Mitigation.
Introducing a new medical device or navigating a site-to-site manufacturing transfer requires precise execution, strict regulatory oversight, and zero operational downtime. Viant's ViaLaunch™ Program Management Framework is purpose-built to address the complex lifecycle requirements of MedTech OEMs worldwide.
Driven by direct engineer-to-engineer collaboration, ViaLaunch™ integrates standardized stage-gate governance, Design for Manufacturability (DFM), and ISO 13485 quality systems to safeguard critical launch metrics—including time to market, unit costs, validation integrity, and supply chain predictability.
ViaLaunch™ combines international program management standards (PMBOK® / EPMO) with Lean Manufacturing and Six Sigma principles to establish total transparency throughout your product transfer or NPI lifecycle.
Proactive identification of technical and supply chain vulnerabilities using FMEA modeling, data-driven customer audits, and structured escalation pathways.
Strict adherence to ISO 13485, FDA QSR, and EU MDR guidelines. Fully documented IQ/OQ/PQ validations guarantee repeatable high-yield production.
Disciplined communication plans, interactive project dashboards, and real-time scope change controls keep overseas buyers informed at every phase.
Your ViaLaunch™ journey begins with a comprehensive technical alignment meeting where we build a customized project charter. Our cross-functional teams systematically navigate feasibility, design validation, tooling, cleanroom assembly, and commercial scaling.
Discover how top MedTech companies leverage ViaLaunch™ to overcome complex engineering hurdles, reduce cycle times, and optimize manufacturing footprint.
Achieved a 30% throughput increase and a 30% cycle time reduction following seamless site-to-site contract manufacturing relocation.
Accelerated market launch by shaving 4 months off the rigorous verification and testing timeline via concurrent engineering.
Saved over 1 year of development lead time for a complex orthopedic instrument delivery system by implementing Lean NPI workflows.
Viant's vertically integrated footprint spans 26 global facilities equipped with ISO Class 7 and Class 8 cleanrooms. We maintain strict compliance to ensure international OEM partners pass regulatory audits effortlessly.
Certified Quality Management Systems across all manufacturing facilities worldwide.
Full compliance with US 21 CFR Part 820 Quality System Regulations.
Technical files and post-market tracking tailored for European market readiness.
State-of-the-art cleanroom manufacturing and sterile assembly environment.
Common queries regarding our medical device NPI, transfer process, and global program support.
ViaLaunch™ is Viant's proprietary program management system aligned with EPMO and PMBOK standards. It provides structured stage-gate governance, risk mitigation, and engineer-to-engineer collaboration to move medical devices seamlessly from development into commercial production.
Viant utilizes rigorous customer audits, cross-functional risk matrices, clear escalation protocols, and robust process validation (IQ/OQ/PQ) to safeguard product quality and avoid supply chain disruptions during site-to-site transfers.
Viant maintains ISO 13485 certification, FDA registration across global manufacturing facilities, and compliance with EU MDR regulations to meet the regulatory demands of international healthcare markets.
Request our complete MedTech Contract Manufacturing & Program Management Catalog to explore technical specs, cleanroom capacity, and global case studies.