Medical Device Regulation 1st Edition

Capture the complexities of medical device law with Medical Device Regulation, 1st Edition by Elijah Wreh — a clear, authoritative guide tailored for professionals navigating regulatory pathways worldwide. This concise yet comprehensive resource translates dense statutes into practical steps for designers, manufacturers, quality managers, and regulatory affairs specialists.

You’ll find straightforward explanations of key concepts such as regulatory strategy, risk classification, compliance pathways, post-market surveillance, and alignment with international standards like ISO 13485. Written in accessible language, the book demystifies the regulatory lifecycle from product development through market entry and ongoing safety obligations, making it ideal for teams preparing for submissions to agencies like the FDA, EU MDR/IVDR, and other regional regulators.

Packed with actionable insights and real-world examples, Elijah Wreh’s first edition empowers readers to reduce time-to-market, avoid common pitfalls, and build robust compliance programs. Whether you work in medtech startups, contract manufacturers, or hospital procurement, this title serves as a practical reference for creating regulatory-ready documentation and strategies that meet global expectations — including US, EU, UK, Canada and emerging markets.

Invest in a resource that combines legal clarity with operational practicality. Order Medical Device Regulation, 1st Edition today to strengthen your regulatory knowledge, streamline approvals, and confidently bring safer medical technologies to patients around the world.

Note: eBooks do not include supplementary materials such as CDs, access codes, etc.