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 9月 29日

GHTF Publishes Unique Device Identification Guidance for Regulators

The Global Harmonization Task Force (GHTF) has issued final guidance on developing a global Unique Device Identification (UDI) system for medical devices.
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2011年 9月 30日

HC Plans Wider Use of Foreign Reviews in Device Licensing Process

Health Canada has published draft guidelines outlining plans to make broader use of medical product...
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2011年 10月 14日

US Senate Bill Targets FDA’s Device Review Process

US medical device industry lobbying efforts against current regulatory practices appear to be working.
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2011年 10月 13日

Eucomed Unveils Five-year EU Healthcare Strategy

European medical technology trade association Eucomed has published a five-year strategy for improving the EU healthcare system by more closely aligning medical technology with health care delivery and reimbursement models.
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2011年 10月 11日

GHTF Proposes Harmonized Conformity Assessment System

The Global Harmonization Task Force (GHTF) is seeking comment on a recently issued proposal to establish a global conformity assessment system with uniform obligations for medical device manufacturers and regulators from market to market.
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2011年 10月 10日

Updated OJEC Standards & Recast of the Medical Devices Directive

As usual, the only thing that stays the same in the EU regulatory system is constant change, and this summer has been no exception.
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2011年 10月 7日

Parallel Review Pilot for Innovative Devices Launched by FDA and CMS

A parallel review pilot program newly deployed by the US FDA and the Centers for Medicare & Medicaid Servic
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2011年 10月 7日

New Study: US Med Tech Industry Losing VC Funding

Venture capital firms are investing less in US medical device and pharmaceutical companies in favor...
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2011年 10月 6日

CDRH Sets Up Pilot Program on Establishing Panel of Outside Experts

The US FDA’s Center for Devices and Radiological Health (CDRH) has launched a 12-week pilot program on it
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2011年 10月 3日

FDA Unveils Two-Option De Novo Approach

The US Food and Drug Administration has published draft guidance establishing two pathways for medical...
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