Quality Control & Compliance
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Bill Maisel – the director of the Office of Device Evaluation within US FDA's Center for Devices and Radiological Health (among other titles) – says there are four things device-makers should do to make sure they succeed during the product-review process.
Latest From Quality Control
Part 3 of Medtech Insight’s feature series on the appraisal of manufacturing capability and maturity – “Medtech’s Next Top Maturity Model” – is discussed on this week’s podcast. Author Shawn M. Schmitt gives details on how Baxter Healthcare, Edwards Lifesciences and other firms weathered their appraisals using the Capability Maturity Model Integration (CMMI) model and method.
Inside Toyota's 'Cult': Car-Maker's Quality VP Tells Device-Makers How They Can Adopt 4-Pronged Quality Strategy
Toyota Motor North America's Kristen Tabar told a roomful of medical device quality and regulatory professionals at a Case for Quality forum that they can infuse quality concepts into every nook and cranny of their firms by adopting the car-maker's quality strategy of reflection, education, celebration and planning. "I don’t want to make it sound like it’s sort of cult-y, but it’s kind of cult-y," Tabar quipped.
With New Initiatives, Case For Quality Embarks On Mission To Create 'Safe Space,' Engage CEOs, #makeCAPAcool
Quality and regulatory officials from Medtronic, Hologic, Baxter Healthcare and Boston Scientific – among others – are working with the joint US FDA/MDIC Case for Quality to fully realize a two-year strategic plan that targets corrective and preventive action (CAPA), CEO engagement in quality activities, career paths in device quality, and more.
The device industry advocacy group is putting the final touches on its free playbook, which draws from proven quality culture work conducted at high-profile companies like Medtronic and Covidien, among others.
Boston Scientific, Edwards Lifesciences, Baxter Used CMMI To Measure Their Manufacturing Capability. Here's What They Said About The Experience
Quality, compliance and regulatory officials at the three large device firms – along with their peers at Steris and CVRx – open up about appraisals conducted at their facilities under a voluntary US FDA pilot program that uses Capability Maturity Model Integration (CMMI) to measure the capability and maturity of their manufacturing sites. Along with providing a step-by-step walk-through of the assessments, the officials explain how a CMMI appraisal is nothing like a typical regulatory audit. They also talk about the types of benefits they're seeing (hint: cost-savings, and better manufacturing capability and quality), and how they network via monthly conference calls linked to the pilot. Also: Baxter Healthcare explains why it made its own maturity model, and how it plans to eventually replace the homemade tool with CMMI at all its facilities.
The third of a multi-part Medtech Insight feature series on the appraisal of manufacturing capability and maturity, and what it means for the medical device industry.
Compliance Corner: Contract Sterilization Can Be The Bane Of Device-Makers. FDA's Device Expert Sees These 6 Issues
US FDA's Phil Pontikos highlights six problem areas related to contract sterilization that agency investigators routinely see when inspecting manufacturing facilities, from aging facilities to troublesome personnel, and more.
The US agency's national device expert is urging device-makers to take a hard look at their quality systems in the wake of a product recall. Phil Pontikos says firms must ask themselves "what broke down in your quality system to allow that to happen." His comments come as FDA grapples with an ever-increasing number of corrections and removals from device companies.
From cautioning against relying too heavily on a vendor's Certificates of Analysis, to advocating for more robust supplier audits, two US FDA investigators and the agency's national device expert offer device-makers advice for keeping vendors in line.
Compliance Corner: FDA Investigator Lists 7 Common Human Factors Problems, Says Usability Is 'Overlooked'
Longtime agency investigator Laureen Geniusz reveals seven usability issues that agency investigators regularly see when inspecting medical device manufacturing facilities – troubles that could jeopardize patient safety. Her chief concern? "Human factors seems to be overlooked and not fully understood," Geniusz says.
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