Passing an FDA Quality System InspectionUnderstand the importance of three overlooked parts: 820, 803, and 806
Mon, 05/16/2016 - 15:09
The Quality System Regulation (QSR) 21 CFR Part 820, aka FDA current Good Manufacturing Practices (cGMP) for Medical Devices, is what regulatory professionals should be referencing in their quality system procedures. Part 820 embodies all the major… MDSAP Reaches for a 2019 Deadline in CanadaWill this be good for Canada?
Tue, 02/02/2016 - 16:49
The International Medical Device Regulators Forum (IMDRF) began a pilot phase for its new Medical Device Single Audit Program (MDSAP) in January 2014. This audit combines regulatory audits the manufacturer would typically face when they sell their… IAF Creates New International Certification DatabaseWill provide easy validation of accredited certifications
Thu, 01/14/2016 - 11:06
On Dec. 23, 2015, a vote was taken among 78 nations with accreditation bodies that are part of the International Accreditation Forum (IAF). From the vote it was determined that a new international database for quality management system (QMS)… Europe Signs Multilateral Recognition Arrangement for ISO 13485Includes a Code of Conduct for notified bodies
Mon, 08/31/2015 - 13:57
The European Cooperation for Accreditation (EA), an association of national accreditation bodies in Europe, has implemented the accreditation requirements of the International Accreditation Forum (IAF) and has signed up for the IAF Multilateral… Increasing Costs of ‘Standards’ Force Industry to Seek AlternativesRegulations and technical standards are not the same things
Mon, 12/15/2014 - 11:55
Medical device regulators around the world often have to assess the cost of a new regulation. Typically there is a study to determine the financial effect on industry and the public. This information is often supplied to lawmakers in their… FDA’s Discouraging Third-Party MDSAPThird time wasn’t a charm, fourth could be a disaster
Wed, 04/23/2014 - 15:15
Congress has mandated that every two years the FDA will have inspected nearly every medical device manufacturer on planet Earth that sells to the United States. This isn’t happening. Some have the illusory hope that the Medical Device Single Audit… Attention Medical Device Manufacturers: RoHS Affects YouThe good news is RoHS compliance is much easier now
Mon, 04/14/2014 - 16:59
Electrically powered medical equipment will soon be subject to the Restriction of Hazardous Substances (RoHS) Directive 2011/65/EU.
As of July 22, 2014, most powered equipment sold within the European Union (EU) must not contain more than the… The Beginning of the End for Fake ISO 13485 CertificatesIAF announces the largest technical trade agreement ever prepared for the medical device standard
Tue, 10/29/2013 - 10:02
Many of us have heard horror stories about ISO certificates that were fakes, or of medical-device quality system audits being performed by persons who were not competent. A recent report published by the European Commission found that two out of 11… European Commission Addresses Notified Body AbuseMedical device makers don’t need to retest to voluntary standards, says EC
Thu, 01/10/2013 - 16:47
Some European Commission notified bodies have been forcing a position that a medical device must conform to the latest technical standards to meet the European legal requirement for “state of the art.” As a result, some manufacturers have been… New Medical Device Standard Puts Health Care at RiskMost medical device manufacturers are small and vulnerable to high costs of compliance
Mon, 03/05/2012 - 17:25
One of the greatest challenges that I have in discussing standards is trying to put things in a context so that all people affected by them can understand how they matter. So I want to start with a simple picture and a remarkable snapshot in time.…
