Medical Device Regulatory Landscape

Medical device development: from prototype to regulatory approval.

The treatment of cardiovascular disease has changed dramatically over the past 2 decades, allowing patients to live longer and better-quality lives. The introduction of new therapies (both drugs and devices) has contributed much to this success. Nowhere has this been more evident than in interventional cardiology, where percutaneous coronary intervention has evolved in the past 2 decades from a...

Mapping the Shh regulatory landscape

Practical, ethical and regulatory considerations for the evolving medical and research genomics landscape☆

Recent advances in sequencing technology are making possible the application of large-scale genomic analyses to individualized care, both in wellness and disease. However, a number of obstacles remain before genomic sequencing can become a routine part of clinical practice. One of the more significant and underappreciated is the lack of consensus regarding the proper environment and regulatory ...

Validating Medical Device Packaging

Trustworthy Medical Device Software

This report summarizes what the computing research community knows about the role of trustworthy software for safety and effectiveness of medical devices. Research shows that problems in medical device software result largely from a failure to apply well-known systems engineering techniques, especially during specification of requirements and analysis of human factors. Recommendations to increa...