As medical device quality assurance and regulatory affairs professionals, it can be challenging to stay on top of changes happening in our industry. Few people have the time to read lengthy articles these days and although many online newsletters exist, they are often packed with PR releases, ads or unrelated information. That is why we started this blog for QA/RA professionals in the medical device and IVD industry. The idea is to give you short updates on quality and regulatory topics that may be of interest to you.

2011年 12月 14日

FDA Guidance on HUD Designations Out for Comment

The US Food and Drug Administration has opened a 90-day comment period for
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2011年 12月 14日

UK Unveils Long-term Telehealth Campaign

The UK Department of Health has undertaken a campaign to expand the use of mobile medical devices and services to cover three million patients over the next five years.
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2011年 12月 13日

Moody’s: US Medical Device Firms Face Soft Organic Growth Prospects

US medical device manufacturers dealing with lower market demand and rising pricing pressure will rely more on acquisitions and stock maneuverings to offset challenging growth prospects.
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2011年 12月 12日

New Position Paper Urges Greater Industry Role in HTAs

In a new joint position paper, European medical technology associations are arguing for
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2011年 12月 7日

Indian Regulators Moving Ahead with Medical Devices Bill

India’s health ministry plans to push forward its proposed amendments to the country’s Drugs and Cosmetics Act that would
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2011年 12月 6日

New US Reimbursement Policy Targets Some Medical Devices

A new Centers for Medicare & Medicaid Services (CMS) policy going into effect early next year will require prior authorization for some medical devices and equipment for Medicare patients in seven US states. The new policy will also require pre-payment of reimbursement claims for some medical devices across 11 US states.
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2011年 12月 2日

GOST-R Certification Replaced & Draft Proposal for Regulatory Overhaul

In addition to new regulations implemented earlier last year, the regulatory system in Russia is poised for a fairly significant update with the expected implementation of the “Administrative
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2011年 12月 1日

German Med-Tech Industry Reports 5% Growth

Germany’s medical technology industry has seen sales rates grow by more than five percent according to a survey by the German Medical Technology Association (BVMed).
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2011年 11月 28日

Eucomed Proposed EU Regulatory Fixes

European medical technology trade association Eucomed has issued a new position paper advocating six major changes to how the European Union regulates medical devices.
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2011年 11月 28日

Aktualisierung der europäischen regulatorischen Anforderungen

In diesem Mitteilungsblatt geben wir Ihnen eine Übersicht von EU-Aktualisierungen aus diesem Herbst.
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