RAPS is Looking for SMEs to Write its Latest Book
RAPS is developing a new topic focused book, Global Postmarketing Requirements, Devices, including In vitro diagnostics (IVDs), SaMD, and SiMD. Topics covered in this book include the global postmarket changes, postmarketing surveillance, device tracking, and other compliance obligations that are integral to the postmarketing phase of the product lifecycle. In addition, the book also delves into how various jurisdictions in the global regulated markets address device cybersecurity compliance in an evolving and increasingly interconnected healthcare ecosystem.
The global regions covered in this book include: the US, Canada, Latin America, Mexico, Brazil, Key LATAM Markets, EU and UK, Asia-Pacific, Middle East, and South Africa.
Table of Contents
Section II: Postmarketing Product Changes
- US
- Canada
- Latin America (Mexico, Brazil, and Key LATAM Markets)
- EU and UK
- Asia-Pacific (Japan, China, Australia, New Zealand, Hong Kong)
- Middle East
- South Africa
Section III: Postmarketing Surveillance
- US
- Canada
- Latin America, Mexico, Brazil, Key LATAM Markets
- EU and UK
- Asia, Japan, China, Australia, New Zealand, Hong Kong, Southeast Asia, South Asia including India
- Middle East
- South Africa
Section IV: Postmarketing Compliance, Inspection, Audits, Enforcement Actions
- US
- Canada
- Latin America, Mexico, Brazil, Key LATAM Markets
- EU and UK
- Asia-Pacific (Japan, China, Australia, New Zealand, Hong Kong)
- Middle East
- South Africa
Section V: Medical Device Tracking
- US
- EU and UK
- Asia-Pacific: Japan, China, Australia, New Zealand, Hong Kong, Southeast Asia, South Asia including India
Section VI: Cybersecurity Postmarketing Requirements
- North America (US and Canada)
- EU and UK
- Asia-Pacific: Japan, China, Australia, New Zealand, Hong Kong, Southeast Asia, South Asia including India
Do you have experience in postmarketing requirements for devices? Would you like to contribute to this new topic-focused reference book for RAPS? To be considered for this opportunity, reply with your resume/CV and a brief statement describing your professional experience with devices post-marketing regulatory requirements.