OPERON ELEVATEPLUS | QUALITY MANAGEMENT SYSTEM
Medical Device QMS Consulting in the USA (ISO 13485, FDA QSR & MDSAP)
Operon Strategist delivers comprehensive QMS consulting built specifically for medical device organizations. From ISO 13485 implementation to FDA and MDSAP readiness, we design scalable, compliant, and inspection-ready quality systems — helping you secure regulatory approvals while building a strong foundation for long-term 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 exposure, structured thinking, and execution-ready expertise
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
End-to-end quality management system implementation, certification, and compliance support for medical device manufacturers aligned with global regulatory requirements
Turnkey QMS Development from Scratch or Remediation of Existing Systems
Strong Integration Between QMS & Regulatory Approval Pathways
Audit-Ready Documentation & Implementation-Focused Approach
Digital QMS (eQMS) Implementation & Process Optimization
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frequently asked questions
What is a Quality Management System (QMS) in the medical device industry?
A Quality Management System is a structured framework of processes, documentation, and controls that ensures a medical device manufacturer consistently designs, produces, and monitors products that meet regulatory and quality requirements.
What is ISO 13485 and why is it important?
ISO 13485 is the international standard specifying requirements for a QMS in the medical device industry; it is widely required or referenced by regulators globally, including the EU, and is often a prerequisite for CE Marking and other approvals.
What is the difference between ISO 13485 and FDA QSR (21 CFR Part 820)?
ISO 13485 is an international standard, while FDA QSR is the US regulatory requirement under 21 CFR Part 820; both cover similar quality principles, but FDA QSR has US-specific requirements around design controls, CAPA, and complaint handling.
What is MDSAP and how does it help manufacturers?
The Medical Device Single Audit Program (MDSAP) allows a single audit to satisfy quality system requirements for multiple regulatory jurisdictions, including the US, Canada, Australia, Brazil, and Japan, reducing the burden of multiple separate audits.
Need a Compliant, Audit-Ready Medical Device QMS
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