Medical device quality assurance and regulatory compliance pdf

Quality assurance qa departments are required to manage the compliance of government regulations and maintain production costs to ensure quality and patient safety. Mar, 2018 regulatory affairs professionals serve a critical function throughout a medical device s product lifecycleleading premarket strategy, drafting regulatory submissions, and ensuring postmarket compliance. Quality systems compliance llc was founded in 2012 by mark allen durivage. Supplier quality agreements regulatory compliance training. For us the benefit of using assurx is the audit trails, electronic signatures and workflow control.

Medical device regulatory compliance, gap analysis, remediation. Adtech medical instrument corporation gary syring compliance. The us fda cgmp had been the only regulatory quality system requirements specifically for medical device until the publication of iso 485. The assurance of continued medical device quality in this context requires a. Basic medical device quality and regulatory compliance and. The relationship between quality and compliance in the medical. Thats why so many medical device manufacturers are investing in integrated medical device quality assurance software systems and services. This is a fundamental misunderstanding of the expectations laid out in 21 cfr part 820 for medical device companies and fdas q10 pharmaceutical quality system guidance for the pharmaceutical industry. Betty lane has over 30 years experience in medical device quality assurance and regulatory affairs. Australian regulatory guidelines for medical devices.

The medical device certificate is part of temple university s graduate program in regulatory affairs and quality assurance. With the rapid changes taking place in medical technologies the regulations and quality requirements also need to keep pace and address the specific needs. Quality assurance testing activities for medical device companies. Quality staff look for problems in processes that might result in nonconforming products, and fix those processes that would otherwise cause defects. Iso is not the only regulatory organization providing standards by which medical device manufacturers must comply. Flexible and easy to use, teamcenter combines a robust set of compliance management, traceability and reporting capabilities to deliver the industrys best solution for medical devices manufacturers facing strict regulatory requirements, increasing competition and demanding timetomarket pressures. The fda assures that the medical devices available in the united states are safe and effective. Quality audits also formalize the monitoring of procedures and products at predetermined intervals. The compliance routes available to be able to ce mark your device, in accordance with the medical devices directive, depend on the classification of your device. Qa professionals oversee operations so products meet current good manufacturing practices cgmp and internal standards. Quality assurance happens throughout the medical device manufacturing process. Who global model regulatory framework for medical devices. Compliance management for medical devices fact sheet.

May 17, 2019 quality assurance managers are tasked with developing quality assurance standards and practices, as well as monitoring and documenting quality improvements and potential issues. She is the founder and president of be quality associates, llc, a consulting company helping small and medium sized medical device and diagnostic companies implement and improve their quality systems. Medical device quality assurance and regulatory compliance. These requirements are based on world health organization guidelines. Mckinsey center for government the business case for. Apply to quality assurance engineer, quality assurance analyst, senior quality engineer and more. Common regulatory compliance issues packaging materials improper justification for the selection of packaging materials lack of data on release sorption leaching study specially for those used in liquid parenteral preparations lack of study to demonstrate integrity of container closure system where applicable. Medical device quality assurance and regulatory affairs. It is not practical or feasible to apply the most rigorous conformity assessment process to all types of devices. Medical device quality assurance and regulatory compliance in 2020. The application for a manufacturing license may include manufacturing processes, product details, and information. Therefore compliance with iso 485 provides a presumption of conformity with the basic european union eu quality assurance requirements for ce marking additional eu requirements apply. On the other hand, mastercontrol, a provider of integrated medical device quality assurance software systems and services, provides the tools it takes to streamline medical device quality assurance and regulatory compliance processes in a centralized online system.

Regulation, risk classification, and open innovation. Top 10 medical device regulations training 10 courses. Reporting directly to president, responsible for creation, implementation and maintenance of the quality system processes, in compliance fda 21 cfr, part 820. Quality and regulatory affairs is a profession which has created from the desire of governments to protect public health, by controlling the security and adequacy of products in regions including pharmaceuticals, veterinary medicines, medical devices, pesticides, agrochemicals, beauty care products and complementary medicines. Ensuring medical device quality also is critical to keeping the bottom line in check and keeping investors, doctors, and patients happy so you stay in business. Despite the lag, use of automation is gradually spreading across pharmaceutical, medical device, and biotechnology companies, from clinical trials to regulatory compliance to the back office. The shifting landscape can be an advantage or a disadvantage to medical device manufacturers. Fda consultants medical device consultants pharmaceutical. Global regulatory requirements for medical devices diva.

Medical device regulations who world health organization. Medical device quality urance and regulatory compliance. In meeting this charge, the agency promotes the development and production of high quality devices. Schedule m describes the quality assurance, selfinspection andor quality audit, and quality control system requirements for medical devices and pharmaceuticals. Overview of the quality system regulation for medical devices. European union medical device regulatory requirements147. European medical device directive 9342eec and en 46001. As a result, it includes some particular requirements for medical devices and excludes some of the requirements of iso 9001 that are not appropriate as regulatory requirements. Medical devices quality management systems requirements. Sample regulatory compliance page for medical device companies. As managers, they are also responsible for supervising teams, and in some cases, hiring and training new employees. To maintain patient safety the eu introduced the eu medical device regulation transforming and modernising the older medical device directive. Reformatted for compliance with new tga style manual 040511. Nov 11, 2019 in fact, any medical device requires a qms quality management system to show the device satisfies regulatory mandates for the making and selling of medical devices.

Read pdf medical device quality urance and regulatory compliance. European union eu quality assurance requirements for ce marking. Understanding medical device quality management system. Mar 29, 2021 fda quality system fda regulatory compliance fda clinical services fda clinical services to the medical device, pharmaceutical, and food industries about us mdi consultants inc.

Medical device quality assurance and regulatory compliance 1st. Fda initiatives that promote the development and production of high quality device design and manufacturing by medical device. Quality assurance services fdamap provides comprehensive range of quality assurance and regulatory gxp compliance services to the pharmaceutical, medical device, biotechnology, dietary supplement and other fdaregulated industries in united states and other countries of europe, south america, and asia. Buy medical device quality assurance and regulatory compliance. In smaller medical device companies, regulatory affairs and quality assurance tasks are often added to the responsibilities of personnel who do not have the knowledge or experience to handle them. Regulation for medical devices fda small business regulatory education for industry redi.

Quality assurance and regulatory affairs for medical devices. As a result, regulatory compliance and ongoing quality system improvements may not receive the attention they require. Freyr provides medical device regulatory compliance, gap analysis and remediation services for medical device manufacturers that span across udi, gdpr, eudamed compliance support, post approval compliance support, consultation and representation services for iso 485. The role of regulatory affairs in the medical device industry. Gain a competitive edge by staying ahead of the curve on changes in medical device quality assurance and regulatory compliance. Reformatted for compliance with new tga style manual. He saw an opportunity to serve the needs of businesses working in the fda regulated industries including medical devices 21 cfr 820, pharmaceuticals 21 cfr 211, tissue 21 cfr 1271. Quality assurance prevents flaws in the way a medical device is manufactured. Part 1 full quality assurance procedures excluding clause 1. The technical requirements also apply when the submitter is not the legal. The fdas regulatory requirements and quality guidelines are evolving to balance safety and innovation. Medical device manufacturing quality and compliance. Medical device quality assurance and regulatory compliance in.

Jul 27, 2016 medical devices including diagnostics. Mckinsey center for government the business case for medical. For comprehensive regulatory information about medical devices and radiationemitting products, including. Qa interview questions medical device quality assurance testing. Depending on the type of medical device, the drug controller general of india dcgi and the state fda will approve or determine the medical device licensing process. In europe, products classified as medical devices are subject to stringent regulatory requirements to ensure the products safety and performance. Quality assurance manual nuclear regulatory commission. The primary objective of this international standard is to facilitate harmonized medical device regulatory requirements for quality management systems. Fda quality assurance services drug medical device. Understanding medical device quality management system qms.

Top 5 regulatory changes to watch for mastercontrol. Quality assurance for medical devices sparta systems. Quality issues rightly concern every stakeholder in the medical device value chain, from manuaf cturers and regual ot rs to payors d, octors, and patients. Maintaining an edge means staying ahead of the competition and regulatory bodies when it comes to medical device quality assurance and regulatory compliance. Nov 19, 2019 5 medical device regulatory compliance problems to watch out for your peers have laid the groundwork before you both good and bad. Medical device single audit program the medical device single audit program mdsap allows a. The critical role of regulatory affairs in the medical device. To earn the medical device certificate, students must successfully complete the five required courses with an overall b 3.

Procrastinating is likely to result in compliance challenges or quality issues. Sessions and speakers are subject to change without notice. Manager, quality assurance controller and postmarketing safety controller. Ce marking medical devices under the european medical device directives, it is recognized as a harmonized standard by the european commission. Quality audits internal quality audits help medical device companies ensure their compliance with internal manufacturing procedures and regulatory requirements. Compliance manager regulatory specialist 400 west oakview parkway oak creek, wisconsin 53154.

Mdmareservestherighttocancelorrescheduleanyprogram,whereupon. With all the fda and iso regulations outlining government and industry standards, medical device manufacturers often spend more time documenting processes to meet standards than they do designing and improving their devices. Some have delivered amazing products that have changed lives, and others have put profits before quality and damaged their companies. Medical devices quality assurance and regulatory affairs our integrated qara offering product compliance design history file management creationremediation harmonization product label package design and implementation process compliance quality system process assessment, audit, and support technical documentation and reporting user manual. Media attention has increased, and investors have severely punished some companies with quality issues exhibits 3 and 4. Medical device companies can use the assurx system to control costs and improve their products while meeting regulatory requirements for closedloop quality management. There are a few strategies medical device manufacturers can implement to satisfy quality assurance and regulatory standards and remain in good standing with the public. Quality assurance and regulatory affairs for medical devices our experience on standards and regulations iso 485, iso 14971, iec 62304, 21 cfr 820. Director, quality assurance and regulatory affairs 100 nagog park acton, ma 01720 re. Sep 06, 2020 quality assurance prevents flaws in the way a medical device is manufactured.

Acquaints developers of medical devices with the basic concepts and major issues of medical quality assurance and regulatory documents, describes the requirements listed in these documents, and provides strategies for compliance with these requirements. Many small companies that serve the medical devices sector, sometimes providing vital components to medical devices, but also have non medical device products, have often adopted iso 9001 in the. Book description acquaints developers of medical devices with the basic concepts and major issues of medical quality assurance and regulatory documents, describes the requirements listed in these documents, and provides strategies for compliance with these requirements. New regulations from the european union, canada, and the united states are being implemented simultaneously, and they will impact companies bottom lines. The pace of innovation and regulatory change will continue to accelerate, so its necessary to take a proactive approach to these quality assurance and regulatory. Mdd the medical devices directive product assurance by dnv gl. Erin keith, associate director, compliance and quality staff, opeq, cdrh, fda. Medical device quality control systems mastercontrol. Medical device regulatory compliance, gap analysis. Automating qa in pharma, biotech, and medical devices. The management fully endorses the quality assurance program as detailed in this manual.

Assurance of medical device quality with quality management. Understanding about the quality and regulatory affairs of. Companies in the medical technology sector are currently facing a triple witching hour for medical device regulatory compliance. Compliance with medical device regulatory changes deloitte us. Performance data and compliance with special controls. This workshop will provide valuable assistance to all medical device companies in developing a sound quality and regulatory system, initiating, handling, monitoring, managing, and maintaining audits, and when to initiate and not initiate audits, the focus will be a basic understanding of quality, quality systems, regulatory compliance, and auditing without confusing everyone with regulatory compliance jargon. A medical device manufacturers quality management system is the foundation for maintaining regulatory compliance, driving improvement and effectiveness, and achieving stakeholder confidence in the manufacturer and their products.