European Union Flag

Why the EU Considers Prescription Support Software a Medical Device

By Emmanuel Garnier

…the obligation to obtain a certification for all prescription support software and dispensation support software. Claimants have put forward that the certification requirement does not comply with European law since…

…the obligation to obtain a certification for all prescription support software and dispensation support software. Claimants have put forward that the certification requirement does not comply with European law since…

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3M Find My Adhesive

Need Help Finding an Adhesive?

…business director in 3M’s Critical and Chronic Care Solutions Division in a company press release. The interactive, intuitive and efficient tool can assist design engineers in an oftentimes unexpectedly challenging…

…business director in 3M’s Critical and Chronic Care Solutions Division in a company press release. The interactive, intuitive and efficient tool can assist design engineers in an oftentimes unexpectedly challenging…

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Ames Gross, Pacific Bridge Medical
Ameing for Asia

Update on Radiology Market in China

By Ames Gross

…but expensive form of radiation to treat cancer, is booming in China. Currently, there are only two operational proton therapy centers, one in Shanghai with technology from Siemens (Munich, Germany),…

…but expensive form of radiation to treat cancer, is booming in China. Currently, there are only two operational proton therapy centers, one in Shanghai with technology from Siemens (Munich, Germany),…

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FDA

CDRH Launches Manufacturing and Product Quality Pilot Program

By MedTech Intelligence Staff

…actions by manufacturers that have shown a history of good compliance through the medical device design and manufacturing process. “The FDA intends to work collaboratively with the applicants to implement…

…actions by manufacturers that have shown a history of good compliance through the medical device design and manufacturing process. “The FDA intends to work collaboratively with the applicants to implement…

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Alert

Lack of Adequate CAPA Procedures Tops FDAā€™s List of Violations

By MedTech Intelligence Staff

…127 Lack of or inadequate process validation: 137 Lack of or inadequate procedures involving purchasing controls: 138 Lack of or inadequate complaint procedures: 269 Lack of inadequate CAPA procedures: 400…

…127 Lack of or inadequate process validation: 137 Lack of or inadequate procedures involving purchasing controls: 138 Lack of or inadequate complaint procedures: 269 Lack of inadequate CAPA procedures: 400…

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Dr. Christopher Joseph Devine, President, Devine Guidance International
Devine Guidance

What, No Installation Records?

By Dr. Christopher Joseph Devine

…explain why installation records associated with their establishment’s equipment are not being properly completed and retained. Such lapses in compliance are just begging for a form 483 observation, which happened…

…explain why installation records associated with their establishment’s equipment are not being properly completed and retained. Such lapses in compliance are just begging for a form 483 observation, which happened…

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ZimmerBiomet

Zimmer Biomet Appoints New President and CEO

By MedTech Intelligence Staff

Today Zimmer Biomet announced the appointment of Bryan C. Hanson as the company’s president and CEO. Hanson was most recently a member of Medtronic’s executive committee and the executive vice…

Today Zimmer Biomet announced the appointment of Bryan C. Hanson as the company’s president and CEO. Hanson was most recently a member of Medtronic’s executive committee and the executive vice…

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Dollar, money

New Medical Startups in Asia 2017

By Ames Gross

…per month, Neofect’s product is almost 10 times cheaper than competitor products, such as the Saebo (North Carolina) and Aider (Korea) gloves. Conclusion Western medtech companies can expect more new…

…per month, Neofect’s product is almost 10 times cheaper than competitor products, such as the Saebo (North Carolina) and Aider (Korea) gloves. Conclusion Western medtech companies can expect more new…

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FDA

CDRH Releases FY2018 Proposed Guidance Documents

By MedTech Intelligence Staff

…policy regarding compliance dates of Class I and unclassified devices, and appropriate use of voluntary consensus standards in premarket submissions for medical devices. Draft guidance priorities include export certificates, the…

…policy regarding compliance dates of Class I and unclassified devices, and appropriate use of voluntary consensus standards in premarket submissions for medical devices. Draft guidance priorities include export certificates, the…

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MedTech Intelligence

2018 MedTech Events: FDA Submissions, Cybersecurity, Recalls and More

By MedTech Intelligence Staff

…how to use statistical methods in medical device development, testing manufacturing and postmarket surveillance. Register for the virtual event, taking place February 13–14 here. Other conferences include Cybersecurity Vulnerability Management…

…how to use statistical methods in medical device development, testing manufacturing and postmarket surveillance. Register for the virtual event, taking place February 13–14 here. Other conferences include Cybersecurity Vulnerability Management…

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