Service
Quality Compliance & Engineering Services:
At Upshot, we embed quality into every stage of the medical device lifecycle. As an ISO 13485:2016-certified partner, we help manufacturers navigate regulatory requirements (ISO 13485, 21 CFR Part 820, IEC 62304) with confidence. Our proactive QA systems, tailored strategies, and hands-on support ensure product safety, regulatory success, and market readiness.
End-to-End Quality Compliance & Engineering for Medical Devices:
Upshot delivers full-spectrum QMS solutions for medical device companies—from design to post-market surveillance. We go beyond box-checking by embedding quality into every stage of the product lifecycle. Our team builds tailored strategies that align with ISO 13485, 21 CFR Part 820, and IEC 62304 to reduce risk, enhance patient safety, and support regulatory success.
Through preventive QA systems and rigorous QC inspections, we ensure product integrity and continuous improvement. Whether you’re a startup or an established manufacturer, we help you meet CE, UKCA, and FDA requirements with cost-effective documentation, audit prep, and ongoing compliance support. UpShot is your partner in building a trusted quality infrastructure that accelerates market access and strengthens your brand.
QMS Services Include
- ISO 13485 QMS Implementation (Global): Establishing a global regulatory-compliant system for medical device manufacturing.
- Medical Device Audit Preparation Services: Comprehensive preparation and expert support for internal and external audits to ensure regulatory readiness.
- Management Reviews: Supporting continuous improvement and global regulatory adherence.
- Customer Focus & Device Safety: Ensuring quality policies align with patient safety requirements.
- DHF and Technical File Outsourcing: Assisting with Design History Files and technical documentation as required per QMS needs.
- Global Regulatory Transition Support for Medical Devices: Assisting with transitions to various global regulatory frameworks.
- Regulatory Affairs Consulting: Providing expert guidance for EU MDR, 510(k), PMA, NMPA, MHRA and CDSCO compliance.
Quality Control (QC)
Our QC team safeguards product integrity through systematic inspection, testing, and issue resolution—ensuring only compliant products reach the market.
- Test method development & validation
- In-process, final, and lot release inspections
- Nonconformance & deviation management
- Material traceability & batch control
- Compliant, repeatable documentation
Together, our QA and QC services create a comprehensive quality framework that prevents issues early and ensures product excellence at launch.
Expanding the Dimensions of Quality
At Upshot, we go beyond traditional QA/QC by embedding quality across six critical dimensions—ensuring excellence at every level of your organization:
- Design Quality
Ensuring safe, effective products through aligned design inputs/outputs, V&V, risk analysis (DFMEA), usability engineering, and DHF compliance. - Process Quality
Optimizing performance with validated processes (IQ/OQ/PQ), SPC, lean principles, SOPs, and continuous improvement (Kaizen, Six Sigma). - Operations Quality
Maintaining consistency through calibrated equipment, traceable data systems, deviation tracking, and quality-driven production planning. - Business Quality
Driving strategic alignment via QMS integration, KPI dashboards, supplier audits, cost-of-quality reduction, and regulatory foresight. - Customer Quality
Enhancing user trust with complaint handling, post-market surveillance, recall readiness, VoC insights, and feedback-to-design integration. - Supplier Quality
Building resilient supply chains through lifecycle management, capability assessments, validation support, risk control, and quality agreements.
