Medical Device Quality Management System (QMS)
Medical Device Quality Management System (Medical Device QMS)
Medical Device Quality management systems (QMS) are essential to ensure the safety and efficacy of medical devices. ISO 13485 is one of the most widely accepted ISO standards of quality management systems for medical devices and provides a framework to ensure that all processes are in line with regulatory requirements.
What is a Medical Device Quality Management System (QMS)?
The medical device quality management system provides a framework for identifying, analyzing, and addressing quality-related issues in a systematic way. It includes activities such as documentation control, management responsibility, product realization, risk management, process control, supplier management, and measurements, analysis and improvement (corrective and preventive action).
In the medical field, a QMS is critical to ensuring patient safety, reducing errors and defects, and improving the overall quality of healthcare products. QMS certification is often required for medical device manufacturers and healthcare organizations to demonstrate their commitment to quality and compliance with applicable regulations and standards such as ISO 13485, FDA 21 CFR Part 820, European Medical Devices Regulation (MDR) and Indian Medical Device Rule 2017 (CDSCO).
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Why Medical Device Quality Management System is Important for Organizations?
- A medical device quality management system process helps to coordinate and direct the organization’s activities to meet customers’ regulatory requirements and to make it effectual and improve its efficiency continuously.
- Implemented and maintained Quality Management Systems have the power to affect all aspects of the organization’s performance.
- A quality management system for medical devices is a set of policies or procedures mainly needed for the planning or execution of the business or the organization.
- The documentation of the QMS for medical devices is to be maintained and controlled, which can impact the organization’s ability to meet the customer’s requirements.
What are the Regulations and Standards Governing Medical Device QMS?
- FDA’s Quality System Regulation (QSR) 21 CFR Part 820
- EU Medical Device Regulation (MDR) 2017/745
- Indian MDR 2017 (Medical Device Rule 2017)
- ISO 13485:2016
- Medical Device Single Audit Program (MDSAP)
- Country specific regulations
How to Get QMS Certification for Medical Devices
- Identify the relevant standards and regulations.
- Develop and implement a QMS that meets these standards and regulations.
- Conduct internal audits to ensure compliance.
- Engage a third-party certification body to audit the QMS.
- Address any non-conformances identified during the audit.
- Corrections of nonconformance found during audit.
What are the Requirements for Medical Device Quality Management System?
- Document control
- Management responsibility
- Resource management
- Human resource
- Infrastructure
- Work environment and contamination control
- Product realization
- Planning of product realization
- Customer-related process
- Design and development
- Purchasing
- Production and service provisions
- Control of monitoring and measuring equipment
- Measurements, analysis and improvements
- Monitoring and measurements (Feedback, Complaint handling, Reporting to regulatory authorities, Internal audit, Monitoring and measurements of process and products)
- Control on nonconforming product
- Analysis of data
- Improvement
When Is a Quality Management System (QMS) Required for Medical Devices?
A quality management system is required for medical devices whenever they are sold or distributed in markets that have regulations or standards governing medical devices.
How Long Does It Take to Implement Medical Device QMS Fully?
The time it takes to implement a medical device QMS fully varies depending on factors such as the complexity of the QMS, the size of the organization, and the level of existing quality controls. However, it typically takes several months to a year or more to fully implement a QMS.
What is Our Role as Quality Management System Certification Consultant?
As a medical device quality management system certification consultant, we analyze the problems & issues that bother clients. As a medical device regulatory consultant, Our medical device QMS consulting services include manufacturing plant layout designs, QMS certification training, manufacturing process, and regulatory approvals. We have an experienced team that has a good hand in auditing, executing, and maintaining all features.
our team is involved in the US FDA, EU-notified bodies, and QMS certification bodies. We have well-built technical expertise to assist and protect your quality systems that can follow the toughest regulatory inspection.
Boost Your Medical Device Quality With Operon Strategist’s QMS Certification Services.
Why Choose Operon Strategist for QMS Certification?
Operon Strategist has substantial experience in regulatory areas required for medical device Quality Management System certification implementation of medical devices, in vitro diagnostic devices, packaging material products, pharmaceuticals products, and combination products. We have handled national as well as international projects and proved ourselves best. The team of Operon strategists can cope with questions like Which QMS standards are applicable? What are QMS certifications? Requirement of QMS? What is compliance and certificate assessment? Etc. All these questions and doubts can be successfully and easily solved with our experienced team which makes justice to your time and money. For further information or inquiries, please don’t hesitate to contact us.
FAQs
What is QMS Service?
These are the set of policies and procedures which enable organizations to identify, control and improve business processes which leads to improved business performance.
Which ISO covers a quality management system for medical devices?
For medical devices, the Quality Management System is implemented according to ISO13485 standard.
What are the benefits of QMS?
QMS is important to build trust as a design or as manufacturing company.
1. It improves processes and increases efficiency.
2. It ensures the consistent quality of products and services.
3. It helps to build a reputation and it creates trust among the customers.