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MedDeviceSupplyChain.com is the premier source for information and practical advice about supply chain quality issues for medical device manufacturers. We provide the latest news and guidance for building and maintaining a supplier quality management program that satisfies the latest global regulatory quality requirements.


FEATURED ARTICLES
Device Tracking Guidance Outlines UDI Integration, Other Concerns
Device Tracking Guidance Outlines UDI Integration, Other Concerns
Manufacturers should update their medical device tracking procedures to account for unique device identifiers, the FDA says in updated guidance. . . .
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IMDRF Details Recognition Process for MDSAP Auditing Groups
IMDRF Details Recognition Process for MDSAP Auditing Groups
The International Medical Device Regulators forum will immediately suspend auditing organizations from the Medical Device Single Audit Program if there is evidence of any wrongdoing during a facility audit. . . .
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EU Launches Surprise Quality Audits Worldwide
EU Launches Surprise Quality Audits Worldwide
Beginning this month, all devicemakers holding CE certificates for devices classified as Class IIa and above should be prepared for unannounced quality system visits by notified body inspectors. . . .
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Expert: Devicemakers Can Avoid Mistakes on Complaints, CAPAs
Expert: Devicemakers Can Avoid Mistakes on Complaints, CAPAs
Devicemakers preparing for an FDA inspection should take steps to avoid some of the most common mistakes, such as lapses in complaint-handling procedures, David Lim, president and CEO of www.RegulatoryDoctor.com, said during an FDAnews webinar. . . .
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Devicemakers Face Challenges Preparing for RoHS Compliance
Devicemakers Face Challenges Preparing for RoHS Compliance
Some devicemakers preparing for the European Commission's regulation on restricting hazardous substances (RoHS 2), which comes into effect in July, are feeling a financial squeeze from its requirements. . . .
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FDA Warns NeoMedix Over Online Promotion of Off-Label Uses
FDA Warns NeoMedix Over Online Promotion of Off-Label Uses
NeoMedix wound up in the crosshairs of FDA investigators for online claims that its Trabectome tissue removal device is effective in treating glaucoma. . . .
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