OPERON ELEVATEPLUS | QUALITY MANAGEMENT SYSTEM
Medical Device Quality Management System (QMS) Consulting
Operon Strategist delivers comprehensive QMS consulting tailored to medical device organizations. From ISO 13485 implementation to FDA and MDSAP readiness, we build scalable, compliant, and inspection-ready quality systems that support both regulatory approvals and long-term business growth.
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Operon ElevatePlus
Quality Management System (QMS) Service Portfolio
ISO 13485 Quality Management System Implementation
Gap assessment against ISO 13485 requirements
Development of quality manual, SOPs, and records
Risk-based QMS structure aligned with device lifecycle
Support for certification audits and surveillance audits
FDA 21 CFR Part 820 Quality System Regulation (QSR)
Alignment of QMS with FDA Quality System Regulation
Design controls, CAPA, complaint handling, and change management
FDA inspection readiness and mock audits
Remediation support for FDA observations
Medical Device Single Audit Program (MDSAP)
QMS alignment with MDSAP audit model
Readiness for audits covering US, Canada, Australia, Brazil, and Japan
Process mapping and evidence-based audit preparation
Support during MDSAP audits and corrective action closure
Electronic Quality Management System (eQMS) Implementation
Selection and implementation of medical device-compliant QMS software
Digitization of SOPs, records, and workflows
Training and system validation support
Integration with regulatory and design documentation
QMS Gap Assessment & Remediation
Evaluation of existing QMS against regulatory standards
Identification of compliance gaps and risks
Corrective and preventive action (CAPA) planning
Documentation remediation and system strengthening
Audit Preparation & Compliance Support
Internal audits and mock regulatory inspections
Support for ISO, FDA, MDSAP, and Notified Body audits
Response to audit findings and nonconformities
Ongoing compliance and lifecycle QMS support
QMS for SiMD/SaMD
QMS implementation for standalone SaMD and embedded SiMD products
Integration of software lifecycle controls with ISO 13485
Alignment with IEC 62304 (Medical Device Software Lifecycle)
Cyber security risk management, data integrity, and secure architecture controls
What Sets Us Apart
Global QMS Consulting Experience Across US, EU, UK, India, GCC & International Markets
Expertise Across ISO 13485, MDSAP, FDA 1 CFR Part 820, & Country-Specific QMS Requirements
Support for Startups, SMEs, & Large Medical Device Manufacturers
Proven Success in Audits, Certifications & Regulatory Inspections
QMS design & implementation – we design, implement, and optimize Quality Management Systems for medical device organizations to meet FDA, ISO 13485, and global regulatory expectations. Our approach addresses common audit gaps, integrates QMS with regulatory and design control strategies, and enables a smooth transition from paper-based processes to scalable digital eQMS platforms, ensuring sustained compliance and operational efficiency.
Operon Quality Management System Advantage
Turnkey QMS Development from Scratch or Remediation of Existing Systems
Strong Integration Between QMS & Regulatory Approval Pathways
Audit-Ready Documentation & Implementation-Focused Approach
