From molecular insight to AI-assisted research
Scientific breakthroughs expand what researchers can model. Clinical usefulness still needs its own evidence.
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Showing 9 of 38 resources
IVDR transition and EUDAMED: two timelines to track
Conditional transition periods and database obligations answer different compliance questions.
Read article and sourcesAntigen-test sensitivity depends on the population
A large hospital study illustrates why intended users, symptoms and study setting belong beside every performance estimate.
Read article and sourcesHMC questions in the FDA’s 2022 IVD town halls
Public transcripts document questions about respiratory diagnostic studies, sample handling and home collection.
Read article and sourcesHMC, HML and a documented laboratory partnership
A 2023 partner announcement provides a dated record of distinct clinical, regulatory and laboratory roles.
Read article and sourcesClass B IVDR planning starts before the final deadline
The transition end date is only one milestone in an eligible legacy device’s conformity-assessment plan.
Read article and sourcesFDA reclassification of two melanoma assessment device types
A 2026 final order changes the pathway for specified adjunctive devices while retaining special controls.
Read article and sourcesEvaluating transparency in AI/ML model characteristics for FDA-reviewed medical devices
Clear model and dataset documentation is essential for interpreting an AI device’s reported performance.
Read article and sourcesPerformance of Rapid Antigen Tests to Detect Symptomatic and Asymptomatic SARS-CoV-2 Infection : A Prospective Cohort Study
Why the timing and repetition of an antigen test matter as much as its single-test sensitivity.
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FROM OUR ORIGINAL RESOURCE CENTER
Knowledge with a history.
Find the latest content and resources from our team of experts to keep you in the know for all things quality and regulatory in the life science industry.
6 historical resources
Intended Use Validation
Medical Device Manufacturers in the United States have to comply with intended use validation (IUV) requirements.Intended use is...
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The FDA, CBD, and OTC Drugs
When making a new product, whether that product is a drug, a medical device, or a combination product, understanding the regulations...
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510k Submissions for Sterile Devices
A lot of work goes into a 510k submission for a medical device. Companies that submit a 510k for a product have to...
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Determining the Right Regulatory Pathway for your Drug
A fundamental question in any drug development program is which regulatory pathway to pursue...
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5 Reasons Why Internal Auditing is Important
An internal audit program is vital for proper monitoring and assurance of products. It is also essential to verify that individual processes...
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Hopkins MedTech Group DBA Hopkins MedTech Compliance is hiring a full-time Clinical Manager.
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Company updates
Public posts from Hopkins MedTech Compliance. Dates below are the original LinkedIn publication dates.
Documented partnerships
HMC and HML are distinct entities. These dated records describe the announced relationships; they do not verify current partner accreditations or service availability.
Hopkins MedTech Lab Services (HML)
DiaCarta's announcement describes HML's laboratory-related work separately from HMC's clinical and regulatory services.
Read DiaCarta's partnership announcementDiaCarta
DiaCarta announced a partnership with HMC and HML for IVD regulatory compliance and laboratory-developed-test validation in the United States.
Read DiaCarta's partnership announcementPublic record
The FDA transcripts document participation in public discussions, not FDA endorsement, certification or product authorization.
FDA IVD town hall: SARS-CoV-2 test development
The transcript records Homer Wu identifying himself with HMC and asking about a pre-EUA combination-test submission.
Read the original FDA transcript (PDF)FDA IVD town hall: respiratory diagnostic studies
The transcript records Homer Wu identifying himself with HMC and asking about an influenza B study outside the United States.
Read the original FDA transcript (PDF)FDA town hall: monkeypox test development
Jennifer Stanford and Homer Wu identify themselves with HMC and ask about specimen handling and home-collection validation.
Read the original FDA transcript (PDF)
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