From molecular insight to AI-assisted research
Scientific breakthroughs expand what researchers can model. Clinical usefulness still needs its own evidence.
Read article and sourcesHOPKINS MEDTECH COMPLIANCE
Medical devices.Clinical studies.Regulatory support.
Clinical performance studies and submission support
for medical devices and in vitro diagnostics (IVD).
MEDICAL DEVICES · IN VITRO DIAGNOSTICS
CLINICAL RESEARCH / REGULATORY SUPPORT
MEDICAL DEVICESAND IVD.
Clinical and regulatory services
From development
to market.
CONNECTED EXPERTISE
Regulatory strategy
Clinical evidence
Global market access
THE ADVANTAGE OF EXPERTISE
Clinical studies and
regulatory submissions.
HMC supports clinical study planning, regulatory submission preparation and quality system documentation.
Hopkins MedTech Compliance works with medical device and IVD companies, including Chinese companies preparing for the US and European markets.
Meet Hopkins MedTechClinical studies
Study documents and data review
Regulatory submissions
Submission documents and evidence
Market entry
US and EU requirements
HOPKINS MEDTECH COMPLIANCECRO for IVD and
Explore our expertiseCRO for IVD and
MedTech Innovations
EXPERTISE THAT CONNECTS
Our areas of service
01
Clinical performance studies
HMC supports clinical performance studies for medical devices and in vitro diagnostics (IVD).
Clinical study services
02
FDA and EU submissions
HMC supports clients preparing FDA 510(k), EUA and European IVDR submissions.
Regulatory submission support
03
Quality and compliance systems
HMC supports quality system documentation and compliance work for medical technology companies.
Quality system services
04
Laboratory support through partners
Laboratory support is coordinated through associated businesses and partners, with the provider and scope confirmed for each engagement.
Laboratory service arrangements
BUILT AROUND YOUR PRODUCT
Medical devices and
in vitro diagnostics.
YOUR FIELD. OUR FOCUS.
Industries
we support.
Find service information for your product category.
SERVICE STAGES
Services across
the product lifecycle.
Explore development, studies, submissions and post-market support.
HOW WE WORK
Discuss the scope
of your project.
Product
Identify the product category and intended use.
Market
Specify the country or region where you plan to submit.
Scope
Discuss study documents, submission materials or quality system support.
Project information
Use the service descriptions to identify the study, submission or quality-system support you need.
Read the service descriptionsPERSPECTIVES & EVIDENCE
Research summaries
and public records.
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.
Read article and sources01—03 / 09
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