Top 10 Reading List for Quality & Compliance Managers within Medical Devices
Regulatory affairs and Quality assurance (RAQA) is a complex journey. Becoming an expert in RAQA takes time. Regardless of where you are at this moment of your journey, either a newcomer or an expert already, there is always room for improvement to adhere to the highest standards of quality, safety, and regulatory compliance.
Our selection of the readings covers a wide range of topics relevant to Quality & Compliance managers within the medical devices industry from foundational principles to advanced strategies. These sources offer a roadmap for navigating regulatory complexities, driving continuous improvement, and fostering a culture of excellence within medical device organizations.
Our Selection
Let’s discover which sources we pick for you and why.
1. ISO and IEC Standards for Medical Devices
You might love or hate standards but understanding and implementing these standards is paramount for medical device manufacturers and Quality & Compliance managers committed to delivering high-quality and safe products and services.
Standards create uniform and transparent routines, reducing misunderstandings and avoiding redundant efforts. They provide clarity to manufacturers and ensure legal certainty, reduce risks related to product liability and lower the time and costs associated with quality assurance documentation.
The important standards in the medical device industry includes:
ISO 13485:2016 for quality management systems
ISO 14971:2019 for risk management of medical devices
IEC 62366-1:2015 for usability engineering in medical devices
ISO 15223-1:2016 for symbols used in medical device labeling
IEC 62304 for the development of medical device software
This list can be expanded with the ISO 13485 handbook, which aims to provide invaluable information and understanding of the requirements set out in the ISO 13485. Designed to serve as a reference rather than a cover-to-cover read, this handbook is structured in line with the clause structure of ISO 13485, facilitating easy navigation and quick access to specific requirements as questions arise during the QMS development or implementation process.
To find out more about which standards are supporting medical device manufacturers you can refer to the International Organization for Standardization and the International Electrotechnical Commission.
2. FDA Device Regulation Overview
Regulatory requirements set by the U.S. Food and Drug Administration (FDA) for medical devices are critical to ensuring the safety and effectiveness of devices distributed in the U.S.
Basic rules that medical device manufacturers in the U.S. must follow:
Establishment registration
Medical Device Listing
Premarket Notification 510(k), unless exempt, or Premarket Approval (PMA)
Investigational Device Exemption (IDE) for clinical studies
Quality System (QS) regulation
Labeling requirements, and
Medical Device Reporting (MDR)
The Overview of Device Regulation provides a concise explanation of the most important requirements, allowing you to brush up on your knowledge or drill down into specific requirements.
3. The Medical Device Coordination Group (MDCG) Guidance Overview
In the dynamic medical device regulatory environment, you can seek clarity and guidance for the effective implementation of EU rules governing medical devices and in vitro diagnostic medical devices.
The MDCG provides a range of documents and guidance to assist stakeholders in applying Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 (IVDR) on in vitro diagnostic medical devices.
These resources provide a general understanding of how MDR and IVDR should be applied in practice. The content of these documents covers a wide range of topics, including borderline and classification, clinical investigation, evaluation post-market surveillance and vigilance, and many others.
4. “Fundamentals of Medical Device Regulations”
The "Fundamentals of Medical Device Regulations, Fifth Edition" by the Regulatory Affairs Professionals Society (RAPS) is a comprehensive compilation that brings together revised chapters from various editions of regulatory affairs textbooks, focusing on medical devices and in vitro diagnostics (IVDs). It serves as both a practical reference and a study tool for individuals involved in regulatory affairs.
The book is divided into three main sections:
Fundamentals of US Medical Device Regulations covers topics such as the history of FDA regulations, regulatory pathways, clinical trials, good manufacturing practices, regulatory strategy, submissions, compliance, postmarketing activities, and more.
Fundamentals of EU Medical Device Regulations delves into the history of EU regulations, enforcement, competent authorities, the new EU Medical Devices and IVD Devices Regulations, legal systems, classification, safety requirements, clinical evaluations, conformity assessments, postmarket requirements, national particularities, combination products, advertising, promotion, and regulatory strategies.
Fundamentals of International Medical Device Regulations introduces readers to international regulatory affairs, covering topics such as compliance, enforcement, counterfeit regulations, pricing, reimbursement, health technology assessment, premarket requirements, quality management systems, in vitro diagnostics, active implantable devices, software, postmarket requirements, and combination products. It provides insights into navigating global regulatory landscapes beyond the US and EU markets.
5. “Medical Device Guidelines and Regulations Handbook”
The Medical Device Guidelines and Regulations Handbook provides a comprehensive overview of key standards such as ISO 13485, ISO 14971 and others in one place.
What sets this resource apart is its focus on practical application. Instead of drowning readers in technical jargon, it presents simplified guidance and regulations in a clear and accessible manner.
6. “Medical Device Quality Management Systems: Strategy and Techniques for Improving Efficiency and Effectiveness”
This book, authored by Manz, delves into the intricacies of creating an effective and efficient Quality Management System (QMS), offering insights into developing a vision, strategy, and tactical plans.
The key focuses are aimed at:
An Effective Quality System part covers regulatory requirements, increasing expectations, and strategies for establishing and maintaining a robust QMS structure.
An Efficient Quality Management System part explores the transition from focusing on the cost of quality to understanding the value of quality, while also addressing common mistakes that organizations should avoid.
The Roles, Responsibilities, Capabilities part discusses the distributed nature of quality within an organization, emphasizing that quality is not solely the responsibility of a single department. It outlines key roles such as the Management Representative and Executive Management, as well as the importance of process ownership and individual capabilities.
Quality Leadership and a Seat at the Table part highlights the value of quality within medical device companies and explores maturity modelling to assess and improve quality practices.
Vision, Strategy, and Quality Planning part guides on developing a compelling vision for quality, aligning strategies with organizational goals, and translating vision into actionable plans.
Improvement: Tools and Techniques explores essential tools and techniques for quality improvement, including Corrective and Preventive Actions (CAPA) and Six Sigma methodologies.
7. “Software as a Medical Device”
The “Software as a Medical Device” will be valuable to those managers interested in the complexity of healthcare software, especially with a focus on software as a medical device (SaMD).
The book brings together the experiences of leading software experts, making it a valuable resource for strategic discussions and decision-making in the field.
Overall, the book aims to make it easier to understand and comply with the regulations governing healthcare software, ultimately promoting the development and availability of innovative healthcare technologies.
8. “Proactive Supplier Management in the Medical Device Industry”
This book focuses on supplier management in the medical device industry and emphasizes the critical importance of ensuring that every component and service used in medical devices meets quality requirements.
It includes practical advice based on real-world experience working with leading medical device companies and contract manufacturers. Moreover, it describes a comprehensive supplier management process, from selection to ongoing proactive management.
The inclusion of real-life examples to illustrate concepts and principles is valuable for those who value practical relevance over theory.
9. "Safety Risk Management for Medical Devices"
The "Safety Risk Management for Medical Devices" book breaks down the risk management process according to ISO 14971 clearly and understandably. It gives you practical, step-by-step instructions and also offers great advice on making product development better.
10. “Handbook of Investigation and Effective CAPA Systems”
The "Handbook of Investigation and Effective CAPA Systems" is an essential resource for professionals in regulated industries, offering comprehensive guidance on conducting investigations and implementing Corrective and Preventive Action (CAPA) systems.
The handbook serves as a comprehensive guide for implementing best practices in CAPA, providing practical examples that are readily applicable also for companies in the medical device industry.
Given the importance of governance, risk management and compliance within the medical device industry in the modern workplace, all your team, not just those in the RAQA department, can benefit from these readings.
They were chosen not only because of their expert advice but also readability and practicability. These resources inspired us and hopefully will inspire you.
Looking for More Compliance Insights and Wants to Be on Track?
If you want to stay on top of the latest trends and strive to optimize your organization's medical device development and QMS, thereby playing a key role in ensuring the production of safe and compliant medical devices, feel free to refer to our guides and blogs or contact us to try a demo.