Service
Quality Built In – Delivered With Precision
A strong quality engineering strategy ensures that medical devices comply with international regulatory standards, meet safety requirements, and perform as intended before entering the market. UpShot offers expert services in product and process verification, risk management, and both pre-market and post-market studies—helping manufacturers streamline production and minimize compliance risks.
Comprehensive Quality Engineering Support
At Upshot Engineering LLP, we don’t just check the box for compliance—we build quality into every layer of your product lifecycle. From early-stage design through post-market surveillance, our team of experienced professionals delivers tailored quality strategies that protect patients, ensure regulatory success, and strengthen your brand reputation.
Quality Engineering Services
Quality Assurance (QA)
We deliver proactive, preventative QA systems that embed quality from design through delivery.
- Focus: Process, systems, and procedures
- Goal: Prevent issues by embedding quality throughout production
- Timing: From design to delivery
- Activities: Monitoring, auditing, optimization, staff training
- Examples: Checklists, internal audits, quality standards
- Perspective: Proactive, preventative, future-oriented
Key QA Services
- Regulatory readiness (FDA, ISO 13485, EU MDR)
- Design controls and documentation
- Risk management (ISO 14971)
- Internal audits, CAPA, and quality planning
- Supplier quality and oversight programs
Quality Control (QC)
Our QC team ensures product integrity through systematic inspection and testing to catch and correct issues before products reach the market.
- Focus: Product integrity, inspection, and testing
- Goal: Detect and correct defects pre-release
- Timing: After production, before market release
- Activities: Sampling, lab testing, nonconformance and defect management
- Perspective: Reactive, corrective, and present-oriented
Key QC Services
- Development and validation of test methods
- In-process, final product, and lot release inspections
- Nonconformance and deviation management
- Material traceability and batch control
- Documentation of repeatable, compliant procedures
Expanding the Dimensions of Quality
Our approach goes beyond standard QA/QC practices. We structure quality into five core dimensions to deliver holistic, organization-wide excellence:
Design Quality
- Design input/output alignment
- Design verification and validation
- Risk management (DFMEA, use error analysis)
- Human factors and usability engineering
- Design History File (DHF) compliance
Process Quality
- Process validation (IQ/OQ/PQ)
- Statistical Process Control (SPC)
- Lean manufacturing integration
- Documented SOPs and work instructions
- Continuous improvement frameworks (Kaizen, Six Sigma)
Operations Quality
- Equipment calibration and qualification
- Data integrity and traceability systems
- Real-time deviation tracking
- Quality-driven production scheduling
Business Quality
- Quality KPI dashboards
- Integrated QMS across departments
- Supplier qualification and auditing
- Quality cost reduction strategies
- Regulatory intelligence and business planning alignment
Customer Quality
- Complaint handling and root cause analysis
- Post-market surveillance and trending
- Recall readiness and execution
- Voice of the Customer (VoC) analytics
- Continuous feedback-to-design loops
Compliance Without Compromise
Whether targeting FDA, ISO 13485, MDR, or MDSAP, we ensure your documentation, systems, and culture are ready for inspection—and built for long-term success.
Why Upshot Engineering LLP?
- Cross-functional professionals with decades of experience
- Proven track record across Class I, II, and III medical devices
- Full-spectrum quality coverage—from design through post-market
- Scalable support tailored to startups, mid-size, and global manufacturers
Why Choose UpShot Engineering?
Several modules that can be used separately or together to adapt to your reality
Regulatory Compliance
Expertise in ISO 13485, FDA QSR, and EU MDR standards.
Data-Driven Process Optimisation
Improve manufacturing efficiency and reduce defects.
Cost-Effective Quality Solutions
Supporting startups and established manufacturers with affordable quality engineering services.
