Quality Management System (QMS) Consultant – Operon Strategist
QMS Certification Services for Medical Devices
A Quality Management System (QMS) is essential for medical device manufacturers to ensure product safety, regulatory compliance, and consistent quality. It integrates processes like design, risk management, manufacturing, and documentation, helping companies meet international standards such as ISO 13485:2016 and US FDA 21 CFR Part 820. Certification proves your ability to deliver safe and effective medical devices while building trust with regulators and clients.
At Operon Strategist, we provide expert QMS consulting to help manufacturers design, implement, and maintain certification-ready systems. From documentation support to ISO 13485 and FDA QSR guidance, we ensure your QMS enhances efficiency, compliance, and market readiness globally.
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What is a Quality Management System (QMS)?
A Quality Management System is a structured framework that integrates processes like design, risk management, manufacturing, and regulatory compliance. Its main objective is to improve product quality, enhance efficiency, and ensure compliance with global regulations.
For international markets such as the US and Europe, manufacturers must align with:
ISO 13485:2016 – the global standard for medical devices.
US FDA 21 CFR Part 820 (Quality System Regulation) – covering design, manufacturing, and control.
Operon Strategist, as ISO 13485 medical device consultants, guides clients in preparing documentation, implementing QMS, and ensuring regulatory readiness.
Why QMS is Important for Medical Device Organizations?
A well-implemented QMS offers several advantages:
Ensures regulatory compliance with FDA, ISO, and EU requirements.
Improves efficiency across operations.
Builds customer trust and reputation.
Reduces risks of non-compliance, recalls, and warning letters.
Provides a framework for continuous improvement.
QMS Certification Standards for Medical Devices
We support medical device manufacturers with multiple QMS certification standards, including:
ISO 13485 Certification – international QMS for medical devices.
US FDA 21 CFR Part 820 QSR – mandatory for US market entry.
ISO 9001:2015 – general QMS standard with risk-based assurance.
ISO 15378 Certification – QMS for primary packaging materials in medicinal products.
Our Role as QMS Certification Consultants
At Operon Strategist, our consulting services include:
End-to-end QMS design and implementation.
Support for ISO 13485 and FDA 21 CFR Part 820 compliance.
Regulatory document preparation and training.
Internal audits and gap assessments.
Assistance in QMS certification audits with notified bodies and regulators.
Benefits of Implementing a QMS with Operon Strategist
Achieve compliance with global standards.
Ensure consistent product quality and patient safety.
Enhance operational efficiency and risk management.
Strengthen customer trust and business reputation.
Get expert guidance for smooth certification audits.
Our experienced consultants have worked with FDA, EU-notified bodies, and global certification agencies, ensuring your systems withstand the most stringent regulatory inspections.
Why Choose Operon Strategist?
Operon Strategist has extensive experience in Quality Management System consulting for medical devices. We specialize in supporting manufacturers across medical devices, IVDs, packaging, and combination products. With our proven expertise, we ensure:
Customized solutions for your compliance needs.
Strong technical support for QMS implementation.
Guidance to overcome regulatory challenges quickly and effectively.
👉 Partner with Operon Strategist for your QMS certification journey and ensure your medical device business meets global compliance requirements.
📩 Contact us today at enquiry@operonstrategist.com to get started.
Get your medical device QMS compliant and audit-ready today.
FAQ'S
A QMS is a structured framework aligned with ISO 13485 and FDA 21 CFR Part 820 regulations, designed to ensure consistent product quality, regulatory compliance, and continual improvement throughout the device lifecycle
ISO 13485 is recognized worldwide as the QMS benchmark for medical device manufacturers. Certification supports CE marking, market access, and signals commitment to compliance and quality to regulators and customers
Operon Strategist guides accurate implementation of the FDA’s Quality System Regulation, including CAPA processes, document control, internal audit readiness, and training, tailored to meet US regulatory scrutiny
Gap Analysis against ISO 13485 / FDA QSR
Development of Quality Manuals, SOPs, and Records
Staff Training, Internal Audit Support, CAPA Management
Complete certification readiness and regulatory liaison for global compliance
With a proven track record of delivering 1,000+ regulatory and QMS projects, Operon Strategist offers expert, tailored support in ISO 13485, FDA, EU MDR, and broader global regulatory frameworks