Streamline Your Medical Device Quality Management System
Ensure regulatory compliance and market access as our Management System Consultants help you implement and maintain the medical device quality management system (QMS) throughout the product lifecycle.
Management Systems
A Management System is a structured framework of processes, policies, and procedures designed to ensure regulated products' safety, effectiveness, and compliance with international regulatory standards. For instance, ISO 13485 for quality, ISO 27001 for information security, and ISO 42001 for AI system providers. Manufacturers aiming to introduce a Medical/IVD/AI-System device to the EU market should implement a Management System that complies with applicable regulations and standards. It is considered best practice, and sometimes nearly mandatory to obtain certification from a certification body (e.g. a Notified Body).
Engaging a Management System consultant with profound expertise and extensive experience in MDR (Medical Device Regulation), IVDR (In-Vitro Diagnostics Regulation) or AI Act (Artificial Intelligence) is vital for successfully implementing a Management System. Our PRRCs (Person Responsible for Regulatory Compliance) and Consultants possess exceptional Management System knowledge and experience, ensuring successful implementation and certification.
Medical Device Quality Management System (QMS)
In the medical device manufacturing industry, safety and quality are paramount. To address these critical needs, the International Organization for Standardization (ISO) developed ISO 13485, a dedicated quality management standard tailored specifically for the medical device sector.
Organisations engaged in designing, producing, installing, distributing, and servicing medical devices should consider implementing and maintaining a QMS that is compliant with the requirements outlined in ISO 13485. Quality Management system (QMS) compliance with the legislative requirements is mandatory to gain approval from regulatory authorities in the target market. It is also essential to obtain the CE marking, allowing the sale of medical devices throughout the European Economic Area, and FDA approval (PMA) or clearance (510(k)) to allow the sale in the United States.
The FDA in the United States has started a process to transpose the current 21 CFR Part 820 Quality System Requirements (QSR), into acceptance of the ISO 13485 standard. This will apply in full as from February 2nd 2026. Additional requirements for the US are clarified in the Quality Management System Regulation (QMSR).
Our QMS Compliance Consultants assist medical device and IVD manufacturers in navigating the complexities of EU MDR and IVDR requirements and those set out by the FDA. Our consultants are experts in developing, implementing, and auditing ISO 13485 QMSs, ensuring effective compliance with the applicable standards for your organization.
Ready to ensure and enhance your medical device quality management system compliance?
Information Security Management System (ISMS)
ISO 27001 is the internationally recognised standard for Information Security Management System (ISMS). It is a structured framework designed to manage and protect sensitive company information. It encompasses policies, procedures, and controls to ensure information confidentiality, integrity, and availability. ISO 27001 provides requirements for establishing, implementing, maintaining, and continuously improving an ISMS.
By achieving compliance with this standard that establishes a framework for protecting operational data and its confidentiality, organisations can mitigate information security and cybersecurity risk.
We have completed various implementations of the ISO 27001 in combination with the ISO 13485, and understand how to best combine such systems to demonstrate compliance.
Consult our ISO 27001 experts for compliant data protection solutions in regulated industries.
Optimised Management System for Enhanced Efficiency
Experienced Management System consultants at MedQAIR refine and improve your Management System so that it operates at its highest efficiency and effectiveness levels. They ensure that all processes, procedures, and protocols within the Management System have been streamlined, standardized, and tailored to meet the specific needs and goals of the organization.
The Management System experts at MedQAIR will offer tailored Management System configurations to match your organization's scope and role. Our consultants will meticulously assess your system for the execution of an effective gap assessment to ensure implementation in an agreed timeline. They will undertake this through remote or onsite internal audits, pinpointing deviations, if any, from the prescribed standards.
Need to implement a robust Management System for your medical/IVD software devices or AI system?
Why MedQAIR as Your (Quality) Management System Compliance Consultant
An effective and optimised Management System provides thorough oversight and compliance throughout the process. Highlights of our Management System consultancy services are as below:
- Our PRRCs with in-depth knowledge of MDR, IVDR, and AI Act legislative frameworks ensure device conformity, in alignment with the Management System standards.
- Policies, procedures, and work instructions are well-documented and easily accessible to all stakeholders.
- Continuous improvement by regularly reviewing and updating the Management System to incorporate feedback, address issues, and adapt to the changes in regulations or industry standards.
- Effective risk management by proactively identifying, assessing, and mitigating risks associated with quality, compliance, and product performance.
- Compliance with standards by aligning Management Systems with relevant regulatory requirements, industry standards (such as ISO 13485, 27001 or 42001), and best practices.
- Seamless collaboration with our clients, understanding their unique challenges and goals to deliver personalized guidance and support.
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Frequently Asked Questions About Quality Management System Compliance
What is a Management System and why is it important?
A Management System is a structured framework comprising processes, procedures, and policies aimed at ensuring that your organisation and its products, whether manufactured or commercialized, meet regulatory requirements. It focuses on safety, security, robustness, effectiveness, and consistent fulfillment of customer expectations.
Medical device industries and organizations must establish and uphold country-specific standards for product distribution to ensure compliance with regulatory requirements and meet market access criteria. A Quality Management System (i.e. per ISO 13485) stands as an integral component throughout the entire lifecycle of a medical device, spanning from its inception in design and development to the stages of manufacturing, distribution, and Post-Marketing Surveillance (PMS).
Bringing together a diverse array of stakeholders, it creates a thorough system to oversee and ensure compliance at every stage. Moreover, maintaining country-specific standards facilitates smooth distribution processes, minimizes risks associated with non-compliance, and strengthens the organization’s reputation in international markets.
When is a Management System necessary for Medical Devices? Explain the Medical Device Quality Management System (QMS)
A quality management system becomes a necessity for medical devices whenever they are intended for sale or distribution in markets governed by regulations or standards specific to medical devices (for example, the European Union or the United States). These regulations may vary from one jurisdiction to another, but they uniformly emphasise the importance of ensuring the safety, effectiveness, and quality of medical devices throughout their lifecycle.
By adhering to Management System guidelines, organizations not only ensure legal compliance but also enhance product quality, foster customer trust, and strengthen their position in competitive markets.
What is the significance of ISO 13485?
The ISO 13485 standard has served as the cornerstone for the medical device quality management system requirements for a considerable period. It is widely acknowledged as the benchmark for Management System requirements globally including Canada and Europe. Its widespread acceptance underscores its pivotal role in ensuring compliance, fostering trust, and enhancing product quality across international boundaries.
Relevant Insights
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