Medical Device Quality Assurance And Regulatory Compliance Pdf
File Name: medical device quality assurance and regulatory compliance .zip
- Medical Devices Directive – 93/42/EEC
- Quality Management & Compliance for Medical Device Manufacturing
- Quality Control Checklist For Manufacturing Pdf
- Quality assurance
Imagine that your medical device malfunctioned during patient use. Do you know whether quality assurance or quality control is responsible? When working through remediation efforts, do you know which quality function demands the attention, or should you make improvements to both? More often than we may like to admit, a vast majority of medical device professionals do not have a full grasp on the acronyms and meanings of core industry terminology relevant to their role.
Medical Devices Directive – 93/42/EEC
Imagine that your medical device malfunctioned during patient use. Do you know whether quality assurance or quality control is responsible? When working through remediation efforts, do you know which quality function demands the attention, or should you make improvements to both?
More often than we may like to admit, a vast majority of medical device professionals do not have a full grasp on the acronyms and meanings of core industry terminology relevant to their role. Quality assurance and quality control are complementary parts of a quality management system QMS , yet serve very distinct roles with different purposes. Without knowing how the two quality functions differ and intersect, your QMS processes will struggle, and more importantly, you'll struggle to ensure your medical device is safe and effective.
This article will clear up any lingering confusion around the two terms quality control and quality assurance, explain how they differ from one another and how they intersect, and how professionals in these roles can leverage certain tools and methodologies to successfully control quality and assure quality.
What is the main difference between quality assurance vs. Quality assurance is proactive and process -focused. Quality control is reactive and product -focused. Quality assurance prevents flaws in the way a medical device is manufactured. Quality assurance happens throughout the medical device manufacturing process.
Quality staff look for problems in processes that might result in nonconforming products , and fix those processes that would otherwise cause defects. Quality control tests products or batches of products to see whether they conform to product specifications. The combination of the two is what gives your medical device company the greatest likelihood of attaining the highest level of quality.
Understanding the definition of quality assurance and the definition of quality control is clearest when you understand the process during which each occurs. Quality assurance happens throughout the product lifecycle. Quality control occurs after a physical product is ready to be shipped. Processes can be healthy or unhealthy, effective or ineffective, efficient or inefficient. Quality assurance involves many different methods performed ongoing for flaw prevention.
The end goal is process improvement of product development and quality management, such that any flaws are reduced significantly if not completely. Despite product teams best efforts, supported by quality assurance helping hew to good processes, some flaws manage to slip by undetected. Quality control is the final line in the medical device manufacturing process.
Quality control checks whether the soon-to-be delivered product is actually free of flaws. If it is, then you can be more confident in its success. Quality assurance and quality control professionals share the same goal—ensuring the production, manufacture and delivery of high-quality medical devices—but assume different roles within a medical device company. On average, a company will have multiple people dedicated to quality assurance and at least one person dedicated to quality control.
Quality assurance staff oversee the medical device manufacturing process to ensure that it meets external standards from regulatory bodies, such as FDA and ISO , as well as internal standards from your company.
The latter name comes from the names of its four-step process: Plan, Do, Study, and Act. Quality assurance testing monitors the medical device manufacturing process to determine whether all requirements are being met. The goal is to identify and correct product flaws, eventually leading to an overall decrease in defects.
Quality assurance testing highlights why we refer to quality assurance as process-oriented. The PDSA Cycle runs continuously, giving quality assurance staff the chance to renew their objectives and implement improved ways of meeting those renewed objectives. Quality audits : where quality staff inspects internal manufacturing procedures and verify whether regulatory requirements are being met. These types of audits typically take place at predetermined times.
Process definitions : where quality staff determines exactly what a process looks like and how it works. Clarity here is essential to conducting testing processes that deliver consistent results. Tool identification and selection : when quality staff selects new equipment or tests existing equipment. For instance, quality staff might test whether a particular manufacturing tool is reliable and whether it can consistently create parts that meet requirements. Combined with the PDSA Cycle, quality staff can use these tactics to offer continuous process improvements.
Unlike the assurances for continuous process improvement described above, quality control begins after product development is complete. Quality control staff have a variety of tools at their disposal. Generally, these methods involve either testing or inspecting the manufactured products to determine whether they conform with predefined product requirements. Quality control staff are responsible for inspecting and giving final review of the batch or lot to ensure that the devices therein are, in fact, ready for sale.
Quality control staff use three primary quality control tactics to find and isolate nonconforming products:. Acceptance criteria : quality control staff are required by FDA to establish a formal document detailing how they will determine whether products conform to product specifications. Quality control staff are also responsible for documenting said acceptance and tracking which products or batches met this criteria and which did not.
Product testing : how quality control staff inspect, test, and verify whether a product is ready for shipping. Corrective and preventive action CAPA management : These investigative events are triggered when quality control staff find a nonconforming product, perform a root-cause analysis, and discover a systemic flaw that led to the nonconformance.
CAPA is the most important tool quality control staff have. Part of the confusion between these terms is due to how and where they intersect. If you keep a few things in mind, however, you can maintain clarity and use the terms correctly. Beyond QA and QC, a QMS formalizes all the policies, procedures, and processes used by medical device companies to ensure safe and effective products.
A QMS is the engine that powers pre- and post-market processes like document control and CAPA , respectively, as well as key company artifacts like a quality manual, design specifications, standard operating procedures SOPs , and much more. Similarly, your QMS has many roles—assuring and controlling quality among them—but the larger goal is to manage quality at the planning and execution stages.
QA teams will use the QMS as one of their tools. Your QMS documents the quality policies and procedures that your company uses to make your medical devices. This documentation covers things like purchasing controls that dictate the standards for raw materials, and production controls that dictate the standards for consistent manufacturing processes. A QMS is just one of the tools that quality assurance teams will use. For medical device manufacturers that take quality assurance and quality control seriously, leveraging the best QMS software is essential.
Here are just a few benefits to consider for what a medical device QMS solution can offer your company:. Your QMS documents product specifications. With the best QMS software, quality assurance staff can easily and immediately access this data, using it to ensure a product meets every necessary requirement.
Your quality system manages document, purchasing, production, and supplier controls. With the best QMS software, you make it easy for your quality assurance staff to oversee these processes, ensure everyone is following the most up-to-date processes, and are able to make necessary improvements instantly.
Your QMS is core to your ability to conduct internal audits. The best QMS software offers audit management that enables teams to proactively catch quality issues before they reach the quality control stage. The best QMS software makes those documents and procedures accessible and useful for whoever needs them through one fully connected system. Get your free personalized demo of our software today!
Looking for an all-in-one QMS solution to advance the success of your in-market devices that can integrate your post-market activities with product development efforts? Advance your knowledge. Stay educated on industry regulations. Grow your business. Greenlight Guru Academy is here! See the Demo. Subscribe See the Demo. Search Results for:. Quality Assurance vs. What is quality assurance vs.
Quality Assurance Definitions Understanding the definition of quality assurance and the definition of quality control is clearest when you understand the process during which each occurs. Quality assurance QA The primary focus of quality assurance is the process.
Quality control QC The primary focus of quality control is the product. Role of quality assurance and quality control Medical Device Professionals Quality assurance and quality control professionals share the same goal—ensuring the production, manufacture and delivery of high-quality medical devices—but assume different roles within a medical device company. Quality assurance responsibilities Quality assurance staff oversee the medical device manufacturing process to ensure that it meets external standards from regulatory bodies, such as FDA and ISO , as well as internal standards from your company.
There are four common quality assurance testing tactics that quality assurance staff use: Quality audits : where quality staff inspects internal manufacturing procedures and verify whether regulatory requirements are being met. Quality Control Responsibilities Unlike the assurances for continuous process improvement described above, quality control begins after product development is complete. Quality control staff use three primary quality control tactics to find and isolate nonconforming products: Acceptance criteria : quality control staff are required by FDA to establish a formal document detailing how they will determine whether products conform to product specifications.
QC vs. QA vs. Here are just a few benefits to consider for what a medical device QMS solution can offer your company: Your QMS documents product specifications.
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Quality Management & Compliance for Medical Device Manufacturing
Medical device regulations across the world are diverse. Each phase in the life span of medical device from development to marketing is regulated. Medical device training will focus on these international regulations related to approval and marketing and will help you to develop and implement effective, consistent and reliable quality management systems. Compliance training will also cover topics such as handling medical device recalls, computer system validation, advertising and promotion, process validation, creating compliant SOPs, medical device risk management and more. Non-compliance with the device regulations will lead to more products recalls, heftier penalties and possible prosecution of manufacturers.
In order to obtain medical device approval in the EU, medical devices must be correctly classified. The MDD divides products into different classes, based on risk and intended use, which determines the relevant conformity assessment procedure. The Medical Devices Directive outlines the minimum requirements for ensuring the safety and performance characteristics for Medical Devices in the European market. It is founded on the following basic principles:. Manufacturers of Medical Devices should demonstrate conformity to all requirements listed within the Directive, Recommendations and Implementing Regulations, in addition to the requirements in subsequent guideline documents MEDDEVs.
Quality Control Checklist For Manufacturing Pdf
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This article discusses governance and implementation infrastructure as critical factors in cultivating a culture of quality and building the necessary trust employees may need to help achieve it. To demonstrate how an increased focus on true quality can benefit all stakeholders, including industry, patients, payers, providers and others, in , the FDA invited medical device manufacturers to participate in a voluntary pilot program. As part of the program, participants agreed to an appraisal of their organizational practices and committed themselves to further innovate their quality practices. In return, the participants experienced streamlined engagements with FDA and reduced surveillance and inspections Figure 1. In September , FDA released a report detailing the successes of the pilot program with the recommendation that the pilot be converted into a fully operational program for the US medical device industry. Across the board, pilot program participants reported an increase in the governance and implementation integration practice areas. However, a culture of quality is much more than simply demonstrating compliant processes.
This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Registered in England and Wales. Number Published on May 5th , the final text of the Medical Devices Regulation constituted major changes for the industry. This flexible online course offers students an excellent opportunity to understand the basics of the entire medical device product lifecycle in the context of these updates. This course will allow you to engage with a leading expert in the field and come to grips with regulatory affairs, quality management systems, risk management, clinical evaluation requirements and general compliance aspects of medical devices.
Each industry will have different interpretations of the concept of Quality and how to prioritize its tenets within their own field of practice, expertise and work experience. Quality in the medical device industry touches every stage of the manufacturing process and the organization. Most medical device manufactures have a dedicated Quality Assurance group that ensures compliance with regulations relating to design, manufacture, and records management. The fundamental principle of medical devices is safety for the user, whether that user is the patient or the caregiver. Safety of medical devices is based on the risk management [i] principles as defined in ISO , which outlines the risk-based approach to ensure Quality and applies to elements such as product safety, operability, packaging, design, and use of these devices.
Increasingly, organizations in the industry are expected to demonstrate their quality management processes and ensure best practice in everything they do. A medical device is a product, such as an instrument, machine, implant or in vitro reagent, that is intended for use in the diagnosis, prevention and treatment of diseases or other medical conditions. ISO is designed to be used by organizations involved in the design, production, installation and servicing of medical devices and related services. It can also be used by internal and external parties, such as certification bodies, to help them with their auditing processes.
The implementation of an effective quality management system has always been considered a principal method for a manufacturer to maintain and improve its product and service quality. Globally many regulatory authorities incorporate quality management system as one of the mandatory requirements for the regulatory control of high-risk medical devices. The present study aims to analyze the GMP enforcement experience in Taiwan between and It describes the regulatory implementation of medical device GMP requirement and initiatives taken to assist small and medium-sized enterprises in compliance with the regulatory requirement.
It is also the most user-friendly from both the end user and administrative perspective. AssurX is 5—10 years ahead of their competitors. Managing industry best practices to drive product innovation and patient safety. AssurX medical device manufacturing quality management software QMS is designed to balance the complexity of global quality management and regulatory requirements while maintaining a high level of flexibility to adapt to continual industry and operational changes.
Following the transition period which is set to end on 1 January , changes will need to take place such that licencing can be independently regulated by the MHRA. Following the Brexit Trade Deal announced on 24th December and the subsequent updates from the MHRA on 31st December, some of the information in this whitepaper has now been superceded. More updates will follow shortly.
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