Research and Development

RSS

The FDA is an inescapable presence in your life. It can be supportive and helpful one day, then turn on a dime and make life quite difficult indeed. But you have a say in the matter. You can control this all-important relationship to your advantage. View

Device manufacture is a complicated business, but few areas are more rulebound than QMS. Many a devicemaker has come up short trying to stay abreast of the FDA’s QSR, ISO 13485:2016, and other ISOs while trying to comply with competence, training and awareness rules. View

Regenerative Medicine outlines the RMAT pathway and breaks down requirements regenerative medicine developers must meet to qualify. The FDA granted RMAT designation to 12 organizations in 2017 — the first year of the program. Now is the time to get in the mix, work with the FDA to develop the program and improve your chance of being one of the next RMAT designees. View

Device quality must be implemented and communicated to the FDA, on pain of warning letters or worse. The rules and procedures are technical, involving both FDA rules and ISO 13485:2016. But mastery can be accomplished in only 90 minute View

“Smart” medical devices offer juicy targets to mischief-makers, and the threat is a global one. From garden-variety hackers, to cyber-mercenaries, to nation-states bent on global chaos, devicemakers face uncharted regulatory and liability risks. View

The FDA’s final guidance on UDI (unique device identification) raises as many questions as it answers. With full compliance for Class I, II and unclassified devices looming, lawyers are hard at work parsing the FDA’s language. View

The device supply chain can include hundreds of companies and stretch around the globe. Maintaining quality is a herculean task, yet the FDA requires it of you — at the risk of Forms 483, warning letters or worse. View

In Risk Management in Clinical Trials Dr. Leister explains the significance of the new focus on risk management and the benefits it can reap. View

Devicemakers face a market upheaval in the EU. A new set of rules — the Medical Device Regulation (MDR) — will soon supplant the longstanding Medical Device Directive, forever changing how you sell medical devices in EU nations. View

Device regulation is about to change in ways large and small, as the CDRH moves toward a total reorganization. After it’s complete, the principal medical device overseer is expected to take a total product life-cycle (TPLC) approach, whereby postmarket realizations are fed back into premarket data requirements. View

The FDA has thrown out 25 years worth of regenerative-medicine regulation. In November the agency issued new rules aimed at clearing a path to market for new therapies. But the ink is barely dry, and pitfalls exist. Right now, wouldn’t it be great to have a knowledgeable lawyer guiding your way? View

“Lean management” has come to the drug and device world, improving quality, ensuring compliance and boosting profits for those who adapt its ways to the production floor. If you’re not among them yet, then listen up. View