Medical Device QMS Harmonization: US Considers Aligning to ISO 13485

USA – Medical Device QMS Harmonization: US Considers Aligning to ISO 13485

US FDA is considering adoption of ISO 13485:2016 quality system requirements for medical device registrants. ISO 13485 would replace FDA Quality System Regulations...
Essure Discontinuation Doesn't Mean the End to FDA Scrutiny

USA – Essure Discontinuation Doesn’t Mean the End to FDA Scrutiny

FDA wants the public to know it is taking steps to make sure the long-term safety profile of a controversial birth control device continues...
FDA Reclassifies Some ECT Devices

USA – FDA Reclassifies Some ECT Devices

Electroconvulsive therapy (ECT) devices used for the treatment of catatonia or a severe major depressive episode associated with major depressive disorder or bipolar disorder...
Health Canada Details Medical Device Action Plan

Canada – Health Canada Details Medical Device Action Plan

Health Canada issued a new action plan on Thursday, detailing a three-part strategy intended to improve safety, oversight and quality in the Canadian medical...
US Regulatory Landscape for Medical Devices: A Year in Review and a Look Ahead

USA – US Regulatory Landscape for Medical Devices: A Year in Review and a...

From a transition to the global standard for quality management systems (QMS) to the revamping of premarket review pathways in the US, the medical...
US FDA Finalizes Guidance on Breakthrough Medical Device Pathway

USA – US FDA Finalizes Guidance on Breakthrough Medical Device Pathway

US FDA has published final guidance on its Breakthrough Medical Device market pathway for novel devices and combination products. The new program incorporates...
FDA previews safety-focused STeP pathway, finalizes breakthrough device guidance

USA – FDA previews safety-focused STeP pathway, finalizes breakthrough device guidance

The FDA today outlined its plans for finalizing guidance on its Breakthrough Device Program as well as plans for a new Safer Technologies Program...
Medical device industry regulation is changing: What you need to know

USA – Medical device industry regulation is changing: What you need to know

The medical device industry has been taking a lot of heat lately when it comes to patient safety. There’s the recent International Consortium of Investigative Journalists’ “Implant...
Bipartisan Bill would allow Drug Imports from Canada

Canada – Health Canada Setting Pre-market Medical Device Cybersecurity Requirements

Health Canada has proposed more formalized cybersecurity requirements for Medical Device License applicants. The Health Canada requirements align with cybersecurity approaches adopted by...
Considering Old and New 510(k) Predicates

USA – Considering Old and New 510(k) Predicates

The 510(k) route to market for Class II devices involves the comparison of the candidate device to a legally marketable (already cleared) device. Note...

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