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Quality Control & Compliance

Set Alert for Quality Control

Quality Should Ride Shotgun As US Auto Makers Rev Engine On Making Ventilators

As American auto giants GM and Ford take the wheel on working with ventilator manufacturers to make the critically needed devices during the COVID-19 pandemic, two longtime quality experts explain where the device and auto companies will find common ground when it comes to quality systems.

Quality Manufacturing Coronavirus COVID-19

Latest From Quality Control

COVID-19 May Delay WHO’s Prequalification Of Devices, IVDs

Work and movement-related restrictions are affecting the ability of companies to provide a timely response to questions relating to their prequalification dossiers.

Quality Safety

COVID-19 Leads FDA To Relax Rules On Surgical Masks, Offer EUAs For Reprocessing Some Respirators

The US agency is relaxing some regulatory requirements on facial masks and actively pursuing ways to reprocess N95 respirators used by medical staff under an immediately-in-effect guidance document.

United States Quality Control

Q4 Recalls Snapshot: Mixed Bag For Industry As Recalls Rise But Number Of Recalled Units Falls

Device makers logged a 14% increase in recalls in the fourth quarter of 2019 – the third quarter in a row that the number of recalled devices went up. Meanwhile, recalled units dropped by 74%.

Recalls FDA

Ford Races To The Rescue: US Auto Maker Partners With GE, 3M To Make Ventilators, Respirators During COVID-19 Crisis

Ford Motor Co. announced partnerships on 24 March with GE Healthcare and 3M Co. to manufacture much-needed medical ventilators and respirators. The auto maker also said it’s developing and testing plastic face shields for health care workers.

Coronavirus COVID-19 Manufacturing

GM Partners With Ventec Life Systems To Make Ventilators

American auto giant General Motors Co. announced late on 20 March that it has teamed up with Seattle-based Ventec Life Systems to manufacture much-needed medical ventilators as the US braces for a strained health care system from COVID-19.

Coronavirus COVID-19 Manufacturing

COVID-19: US Auto Giant General Motors Wants To Make Ventilators, Trump Says; Ford And Tesla Also Express Interest

President Trump said on 20 March that GM wants to manufacture ventilators, a medical device that’s in high demand as the US health care system prepares for an onslaught of patients infected by the novel coronavirus. Fellow auto manufacturers Ford Motor Co. and Tesla Inc. also say they’re willing to make the complex products.

Coronavirus COVID-19 Manufacturing

‘We’re Not Making Hubcaps’: Why Trump’s Wartime Approach To Manufacturing Medtech For COVID-19 Is Making Industry Sweat

Two Hogan Lovells attorneys say the medical device industry is jittery about President Trump’s 18 March invocation of the Defense Production Act. That’s because the DPA gives the government broad authority to, among other things, order manufacturers to make particular products in a time of great national need. That can be a problem if those companies can’t make complex products like ventilators – or don’t make devices in the first place. After all, “we’re not making hubcaps. We’re making important devices,” Hogan Lovells partner Mike Heyl tells Medtech Insight.

Coronavirus COVID-19 Manufacturing

COVID-19: US FDA’s Hahn Slams The Brakes On Domestic Inspections ‘For The Health And Well-Being Of Our Staff’

A little more than a month after it put the kibosh on conducting facility inspections in China, the agency announced late on 18 March that it was suspending routine surveillance audits in the US, too.

Coronavirus COVID-19 FDA

US Senate Bill Aims To Break America’s Addiction To Foreign Medical Supply Chains

The US government will study ways to reduce American manufacturers’ dependence on a foreign supply chains for devices and drugs under a bill introduced on 12 March by Sens. Lamar Alexander and Dick Durbin.

Policy Legislation
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