Accelerating Medical Device Development. Engineering Excellence. Ensuring Compliance. Delivering Quality
Strategic Partners in Medical Device Development, Quality, and Regulatory Excellence
Upshot is a specialized consulting partner offering end-to-end medical device engineering solutions. We work closely with manufacturers to manage the complete product development lifecycle—from initial concept through design, development, regulatory approvals, market launch, and post-market support.
As your trusted engineering consultant, we navigate every phase of development with precision and care. Our deep expertise ensures your product meets the highest standards of quality and complies with global regulatory requirements. Our services span concept development, engineering design, regulatory strategy, market readiness, and post-market compliance.
In an industry that demands both innovation and rigor, Upshot Engineering enables you to bring breakthrough medical technologies to market—faster and smarter. We help you meet complex regulatory and quality challenges head-on, without compromising speed or performance.
Why Leading Medical Device Companies partner with Upshot?
End-to-End Product Development Expertise
Our team of seasoned engineers brings deep knowledge of global regulatory standards, including FDA, EU MDR, ISO 13485, NMPA and more. We’re the go-to engineering partner for medical device manufacturers tackling complex, high-stakes projects.
Turn Key Service
We don’t just support tasks—we take full ownership of your product development journey from concept to commercialization. With our experience-driven decision-making approach, we work independently and efficiently—so your team stays focused, not distracted
Cost Efficiency & Scalable Resources
We offer scalable engineering services tailored to startups and emerging innovators—without enterprise-level price tags. Top-Tier Talent Without the Top-Tier Costs.
Accelerated Time-to-Market
By managing the full product lifecycle, we free your team to focus on innovation while we drive execution and compliance.
How We Help?
From early-stage product development to post-market compliance, we provide tailored Engineering services to keep your innovation and compliance on track.
New Product Development (NPD)
End-to-end support from concept to commercialization, Design requirements, risk analysis, V&V, and design transfer. Full ownership of DHF and Technical File creation, Audit-ready documentation and regulatory compliance built in
Quality Compliance & Engineering Services
Compliant QMS implementation (ISO 13485, 21 CFR 820, IEC 62304), expert support for design controls and risk management, and end-to-end supplier quality oversight
Regulatory Affairs
Global regulatory strategy and submission support, including EU MDR, 510(k), PMA, NMPA, MHRA and CDSCO.
Sustenance Engineering
Continuous maintenance of DHFs, License renewals, standard upgrade, risk files, and regulatory reporting for legacy products.
Software as a Medical Device (SaMD)
Ensuring compliance with IEC 62304 and integration of usability standards like ISO 62366-1.
Manufacturing & Operations Support
Process optimization, IQ/OQ/PQ, and production documentation for efficient operations.
Post-Market Support
Assistance with PMS, PMCF, CER, and ongoing risk file updates based on real-world data.
Staff Augmentation
Flexible resourcing with skilled engineers for short- and long-term assignments both onsite and offshore.
Who We Partner With
Startups & Emerging MedTech Companies
We provide cost-effective engineering, Quality and Regulatory support across the full product lifecycle—from New Product Development (NPD) and Quality Management System (QMS) documentation to market launch—helping young companies scale efficiently and compliantly.
Established Enterprises
We partner with global medical device enterprises through flexible, scalable engagement models. Acting as an extension of your team, we take full ownership of key product development activities—including Design Controls, DHF management, quality engineering, regulatory submissions, and manufacturing readiness. For large manufacturers with mature product lines and complex operations, we provide expert support to maintain regulatory compliance and process rigor. Upshot minimizes risk by ensuring strict adherence to global quality and regulatory standards, enabling safe and sustained growth.
Surgeons & Medical Innovators
We partner with clinicians and inventors to transform ideas into reality—developing custom products tailored to surgical needs and guiding innovations from concept to commercialization. Our support spans design, prototyping, regulatory pathways, and market entry across global regions.
What Clients Say About Upshot
Discover how our clients describe their experience partnering with us
