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

…today. Proton beam systems are currently only made by foreign manufacturers, and cost between $30-$50 million per system. However, Chinese companies are investing in foreign manufacturers. In 2015, proton therapy…

…today. Proton beam systems are currently only made by foreign manufacturers, and cost between $30-$50 million per system. However, Chinese companies are investing in foreign manufacturers. In 2015, proton therapy…

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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

…attributes of a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA. (September 2017). ELITech Group B.V. 9/20/17. Inspections, Compliance, Enforcement, and Criminal Investigations. Accessed…

…attributes of a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA. (September 2017). ELITech Group B.V. 9/20/17. Inspections, Compliance, Enforcement, and Criminal Investigations. Accessed…

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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

…medtech technologies coming out of the Asian market going forward. Some of these Asian technologies will compete with existing Western products. Some Asian medtech companies and their products may be…

…medtech technologies coming out of the Asian market going forward. Some of these Asian technologies will compete with existing Western products. Some Asian medtech companies and their products may be…

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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

From learning how to plan for FDA submissions to real-world tools to manage risk to addressing critical cybersecurity challenges, MedTech Intelligence has several practical workshops and conferences for the first…

From learning how to plan for FDA submissions to real-world tools to manage risk to addressing critical cybersecurity challenges, MedTech Intelligence has several practical workshops and conferences for the first…

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Medtech question

Themes of Risk and Uncertainty Continue for 2018

By Maria Fontanazza

…top 12 issues: The healthcare industry tackles the opioid crisis Social determinants come to the forefront Price transparency moves to the state house Natural disasters create devastation that lasts long…

…top 12 issues: The healthcare industry tackles the opioid crisis Social determinants come to the forefront Price transparency moves to the state house Natural disasters create devastation that lasts long…

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