Service
Sustenance Engineering for Medical Devices
Maintaining global regulatory compliance and keeping medical devices up to industry standards requires continuous documentation updates, risk assessments, and engineering change management. UpShot Engineering provides expert sustenance engineering services to help manufacturers manage product compliance, update design history files, and ensure long-term product reliability.
Comprehensive Sustenance Engineering Support
Our team ensures your medical devices stay compliant with ISO 13485, FDA QSR, and EU MDR by maintaining accurate documentation, risk management reports, and design control records. With a structured approach, we help businesses reduce compliance risks and improve product lifecycle efficiency.
Sustenance Engineering Services
Product Compliance – DHF Management
Organising and maintaining the Design History File (DHF) for full regulatory alignment.
Engineering Change Management
Implementing design modifications while ensuring compliance and traceability.
Compliance with Design Control Requirements
Maintaining adherence to FDA and ISO 13485 design control standards.
Risk Management Documentations
Evaluating and mitigating potential risks to ensure device safety and performance.
Technical Documentation & Reporting
Preparing detailed technical files, reports, and audit-ready documentation
