RAPS is recruiting experienced regulatory professionals with a knack for wordsmithing to help author the next iteration of its landmark book on the regulation of medical devices. The brand-new Fundamentals of Medical Device Regulations: A Global Perspective will expand on the first-of-its-kind work found historically in Device Fundamentals by including comprehensive worldwide information on the lifecycle of devices, from cradle to grave. This book will include cutting- edge topics not found in Device Fundamentals, including artificial intelligence, machine learning, real-world evidence studies, human factors studies, digital health, stability testing, biocompatibility, and more. Special topics will also be broached, including in vitro diagnostics, laboratory-developed tests, radiological health, pediatrics, and combination products, among others.
Regional content will be expanded to include the Americas (principally Argentina, Canada, Chile, Mexico, and US); Europe (EU, Switzerland, and UK); Brazil, Russia, India, China, and South Africa (BRICS); Australia, Japan, Korea, New Zealand, Singapore, Thailand, and Vietnam (APAC); Middle East North Africa (MENA); and Africa.
The book is divided into 43 chapters, covering eight overarching sections:
Section I: General Information
- Chap. 1: Medical Devices: A History
- Chap. 2: Overview of Medical Device Policy and Regulation
- Chap. 3: Key Regulatory Agencies and Authorities
- Chap. 4: Standards Organizations
- Chap. 5: Device Classification
Section II: Device Design & Development
- Chap. 6: Quality Systems (including Quality Systems Inspections and Audits)
- Chap. 7: Risk Management
- Chap. 8: Design Controls
- Chap. 9: Verification & Validation
- Chap. 10: Lifecycle Management (TPLC)
- Chap. 11: Labeling
Section III: Nonclinical Testing
- Chap. 12: Overview/Role of Nonclinical Testing
- Chap. 13: Sterilization
- Chap. 14: Biocompatibility
- Chap. 15: Electromechanical
- Chap. 16: Stability Testing
- Chap. 17: Animal Studies
Section IV: Clinical Testing
- Chap. 18: Clinical Trial Design and Planning
- Chap. 19: Conducting Clinical Trials
- Chap. 20: Real World Evidence (RWE) Studies
- Chap. 21: Human Factors Studies
- Chap. 22: Clinical Trial Applications (IDEs, ITAs, etc.)
Section V: Premarket Regulatory Submissions
- Chap. 23: Preparing a Medical Device Submission
- Chap. 24: US Marketing Pathways: 510(k), De Novo, PMA, HUD/HDE, Breakthrough Devices
- Chap. 25: European Marketing Authorization and CE Marking
- Chap. 26: Other International Marketing Pathways
- Chap. 27: Negotiating and Communicating with Regulatory Authorities (including Pre-submission Consultation Meetings, etc.)
Section VI: Postmarket Considerations
- Chap. 28: Unique Device Identification (UDI)
- Chap. 29: Postmarket Surveillance and Reporting
- Chap. 30: Adverse Events and Complaint Handling
- Chap. 31: Recalls and Other Field Actions
- Chap. 32: Advertising and Promotion
- Chap. 33: Regulatory Enforcement (warning letters, untitled letters, etc.)
- Chap. 34: Market Access: Reimbursement
Section VII: Special Topics
- Chap. 35: IVDs
- Chap. 36: LDTs
- Chap. 37: Radiological Health
- Chap. 38: Combo products
- Chap. 39: Pediatrics
Section VIII: AI & Software Tech
- Chap. 40: Software as a Medical Device (SaMD)/Software in a Medical Device (SiMD)
- Chap. 41: Digital Health
- Chap. 42: Cybersecurity
- Chap. 43: Machine Learning & Artificial Intelligence (AI)
When applying, please identify the chapter you are interested in authoring. If applying for more than one chapter, list your selections in the order of preference.
Authors and author groups will have approximately eight weeks to develop their first complete draft. There is no minimum page count for the chapters; however, they are not to exceed 20 pages, including tables and figures.
Apply today if you and/or someone you know would be a great fit as an author – and be part of a unique professional experience!
Please apply by Friday, 5 January 2024