February 8, 2023

Quality Systems: Considerations When Selecting a Contract Manufacturer

Getting quality medical devices from a reliable contract manufacturer is essential for the successful functioning of any healthcare facility. A medical contract manufacturer should have criteria-driven systems that guarantee high-quality products, timely deliverables, secure data storage, and respect for regulations. But how can you be sure the contract manufacturing partner you choose will meet all these standards? 
Let's explain what makes an ideal quality system in a medical contract manufacturer and why it's crucial to find one with such systems.

What is a Quality Management System?

medical quality management system is a comprehensive set of processes and activities designed to ensure the highest levels of patient care. It serves as a bridge between clinical and administrative staff, ensuring that all aspects of healthcare delivery are managed efficiently and effectively. Medical quality management systems are also used to monitor patient safety, improve outcomes, increase efficiency, reduce costs, and optimize resources.

Quality management systems for medical devices typically cover a wide range of components. These include risk management, accreditation standards compliance, infection control strategies and policies, process improvement initiatives, compliance with HIPAA and CLIA requirements, health promotion activities, patient education programs, workforce development initiatives, etc. It strives to create an environment where quality patient care is delivered consistently throughout an organization.

They are divided into two main components: Quality Assurance (QA) and Performance Improvement (PI). QA focuses on identifying, measuring, and reducing medical errors, while PI looks at improving the overall quality of care by making changes to processes and procedures. QA helps ensure that healthcare services are delivered under established standards, while PI seeks to identify opportunities for improvement in patient safety, clinical effectiveness, cost-effectiveness, and efficiency.

Key Elements of a Quality Management System

A medical quality management system for contract manufacturing is an important tool for healthcare organizations to ensure that quality standards are met and maintained. It provides a framework for managing performance, identifying and correcting deficiencies, improving patient safety, and ensuring compliance with regulatory requirements. The following elements should be included in a quality system for contract manufacturing medical devices:

  • Quality Policies and Objectives: Quality policies define the goals of the organization's quality management system. These objectives must be realistic, achievable, measurable, and consistent with organizational values.
  • Measurement: To assess whether organizational goals are being achieved, meaningful metrics must be identified to track progress toward those objectives. This data should be collected regularly to identify and address trends.
  • Quality Improvement Process: Quality improvement processes should include strategies for identifying areas of potential improvement and developing and implementing plans to address deficiencies. Quality improvement initiatives should be evidence-based, systematic, collaborative, and focused on improving quality outcomes.
  • Education and Training: Staff must have access to relevant education and training materials to acquire the necessary knowledge. The organization must also provide ongoing support for staff who need refresher courses related to new technologies.
  • Documentation: Detailed records must be maintained of all quality management activities conducted by the organization. These include data collection results, actions taken after reviews and audits, and improvements made following assessments.
  • Risk Management: Organizations must identify, assess and manage all potential risks associated with their operations. The organization should also establish a process for reporting incidents and evaluating the root causes of these events.
  • Audits: Organizations should conduct periodic audits of processes, procedures, and areas where improvement is needed. Audits should include internal reviews conducted by staff members and external assessments.

Medical Device Classifications

Medical device classification is a system used by regulatory authorities and healthcare professionals to identify risks associated with medical devices. The primary purpose of medical device classification is to protect patients from unsafe or ineffective products and ensure accurate labeling for end users.

The Food and Drug Administration (FDA) oversees all aspects of medical device regulation through its Center for Devices and Radiological Health (CDRH) in the United States. There are three basic classes of medical devices: Class I, Class II, and Class III. In addition to these classes, other classifications may exist based on the intended use of the product.

Class I devices generally pose little or no potential risks to patients and typically require minimal testing before marketing. Examples of Class I devices include simple medical instruments, surgical and infection control, and suture threaders.

Class II devices are considered more complex than Class I devices and generally require special controls such as performance tests or labeling requirements to ensure safety and effectiveness. Examples of Class II medical device products include organ transport & preservation systems, infusion pumps, incubators, and dialysis machines.

Finally, Class III medical devices are considered the most complex products on the market because they typically support or sustain human life. As a result, these devices must undergo extensive premarketing testing before approval by the FDA is granted. Examples of Class III medical device products include heart valves, implantable pacemakers, defibrillators, glucose monitors, diagnostic ultrasound systems and ventilators.

Do Your Due Diligence

Quality contract manufacturing should have systems to ensure that medical devices are being made to the highest standards possible. When considering a potential partner, ask about their quality control procedures. You can also request a tour of their facility to see these processes. Pay attention to the cleanliness of the plant and how employees interact with each other. This will provide insight into the culture of the company.

By finding a quality contract manufacturer for medical devices, you'll be assured that your products are being made by a team that cares about quality as much as you do.  Contact a member of the Sanbor Medical team today!

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