Medical Devices: Regulations, Standards and Practices
by Seeram Ramakrishna, Lingling Tian, Charlene Wang, Susan Liao, Wee Eong Teo · Seeram Ramakrishna, Lingling Tian
Overview of the standards and approval frameworks governing medical devices, including ISO risk and quality standards, classification schemes, safety and clinical testing, and harmonization efforts. Aimed at engineers designing products that must survive regulatory review.
This link may earn us a small commission at no extra cost to you. Affiliate disclosure
More resources on Medical Device Regulation
RAPS Regulatory Affairs
Professional society for regulatory affairs in drugs and medical devices. Hosts the RAC certification, online courses, and the Regulatory Focus news service. Use it to track regulatory developments and see what the profession expects practitioners to know.
FDA Medical Devices
The FDA device center portal: classification database, premarket pathways such as 510(k), De Novo, and PMA, guidance documents, recalls, and postmarket surveillance. Primary source for determining what a specific device actually requires before it reaches market.
Medical Device Regulation
Learn medical device regulations from the FDA! This course covers key aspects of compliance and regulatory pathways.
DeviceTalks
MassDevice podcasts bring you the medical device world's hottest news, straight from the mouths of the industry's leaders.
Medical Device Regulatory Practices
Practitioner guide to device regulation across major markets, covering risk classification, design documentation, clinical evaluation, submissions, and post-market controls in the US, EU, and emerging markets. Readers gain a comparative view of how requirements differ by region.
medtechintelligence.com
MedTech Intelligence is a news and analysis site for the medical device industry, providing regulatory updates, standards and policy guidance, and practical articles on quality systems, compliance, and market access for FDA and EU MDR.