J&J Abiomed Logos

Johnson & Johnson to Expand Cardiovascular Segment with Abiomed Acquisition

By MedTech Intelligence Staff

Johnson & Johnson has entered into a definitive agreement to acquire Abiomed, developer of breakthrough heart, lung and kidney support technologies, for approximately $16.6 billion. The transaction—expected to be completed…

Johnson & Johnson has entered into a definitive agreement to acquire Abiomed, developer of breakthrough heart, lung and kidney support technologies, for approximately $16.6 billion. The transaction—expected to be completed…

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BlackHägen facility

BlackHägen Design Expands Its MedTech Research and Design Capabilities

By MedTech Intelligence Staff

company uses a systematic methodology to translate research insights into design requirements. Its Quality Management System is structured to be compatible with both 21CFR 820 (FDA) and ISO 13485.  …

company uses a systematic methodology to translate research insights into design requirements. Its Quality Management System is structured to be compatible with both 21CFR 820 (FDA) and ISO 13485.  …

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FDA

FDA Updates Guidance on Deficiencies in Accordance with Least Burdensome Provisions

…2023 Through Fiscal Year 2027 Commitment Letter. In addition, the guidance describes suggested formats for FDA staff to communicate deficiencies, and for industry to use for responses to such requests,…

…2023 Through Fiscal Year 2027 Commitment Letter. In addition, the guidance describes suggested formats for FDA staff to communicate deficiencies, and for industry to use for responses to such requests,…

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Veeva Logo

Veeva Introduces MedTech-Specific Vault CRM

By MedTech Intelligence Staff

…application built for medtech sales teams, key account managers and medical affairs professionals. Built on the Veeva Vault Platform, Vault CRM allows companies to bring together commercial functions across sales,…

…application built for medtech sales teams, key account managers and medical affairs professionals. Built on the Veeva Vault Platform, Vault CRM allows companies to bring together commercial functions across sales,…

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Tim Brown

Bridging the Design Development and Quality Management Chasm

By MedTech Intelligence Staff

…use cases that we’re starting to see, especially on the design side of things, are with the computer-aided design (CAD) models. For example, if a component of the project is…

…use cases that we’re starting to see, especially on the design side of things, are with the computer-aided design (CAD) models. For example, if a component of the project is…

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LaĂ­s Junqueira
Soapbox

Nudging Towards Safer Decision Making

By LaĂ­s Junqueira

…to the MedTech Intelligence weekly newsletter to stay up to date on the latest news and information on medical device development and regulation. An important part of this issue is…

…to the MedTech Intelligence weekly newsletter to stay up to date on the latest news and information on medical device development and regulation. An important part of this issue is…

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Jenna Wagner
Soapbox

Life Sciences Labeling for Patient Safety

By Jenna Wagner

…supply chain requirements can be complex. Enterprise labeling systems can equip medical device companies with the tools to make compliant labeling accurate, efficient and scalable.   References: [1] https://teklynx.com/en/support/learn/media-library/case-studies/top-clean-injection?utm_source=medtech_intelligence&utm_medium=media_relations&utm_campaign=life_sciences  …

…supply chain requirements can be complex. Enterprise labeling systems can equip medical device companies with the tools to make compliant labeling accurate, efficient and scalable.   References: [1] https://teklynx.com/en/support/learn/media-library/case-studies/top-clean-injection?utm_source=medtech_intelligence&utm_medium=media_relations&utm_campaign=life_sciences  …

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Critical Manufacturing and Dataworks

Critical Manufacturing Partners with Dataworks To Enhance CSA Support

By MedTech Intelligence Staff

pdfs. However, regulatory bodies, such as the FDA, are encouraging companies to take a more automated approach using computer system assurance (CSA). We are in a strong position to support…

pdfs. However, regulatory bodies, such as the FDA, are encouraging companies to take a more automated approach using computer system assurance (CSA). We are in a strong position to support…

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Team work lightbulb

CDRH Launches Pilot Program To Reduce Device Approval Times

By MedTech Intelligence Staff

…The TAP Pilot is a new component of the Medical Device User Fee Amendment (MDUFA V) Agreement, which was signed into law on September 30, 2022, and reauthorized for five…

…The TAP Pilot is a new component of the Medical Device User Fee Amendment (MDUFA V) Agreement, which was signed into law on September 30, 2022, and reauthorized for five…

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FDA

FDA Issues Final Guidances on Postmarket Surveillance and Post-approval Studies

By MedTech Intelligence Staff

…and how to submit postmarket surveillance reports, including content and format of reports Evaluation of reports and possible FDA actions after completion Failure to comply Public disclosure of postmarket surveillance…

…and how to submit postmarket surveillance reports, including content and format of reports Evaluation of reports and possible FDA actions after completion Failure to comply Public disclosure of postmarket surveillance…

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