CONNECTED EXPERTISE
Clinical research and
regulatory services.
Browse support for study planning, regulatory submissions, quality systems and post-market work.
Market Entry
US Sales Office
HMC supports China-based medical technology companies planning US sales operations, including sales processes and market information. The engagement is commercial support; product-specific regulatory submissions are scoped separately.
Marketing
HMC supports medical device businesses with market information, branding and distributor outreach for US market entry. Product claims and promotional scope require product-specific review.
Market Research
HMC supports medical technology companies reviewing target markets and commercialization requirements. Research scope is defined around the product category, market and regulatory questions that need investigation.
Clinical Trials
Clinical study
HMC supports medical device and in vitro diagnostic (IVD) companies with clinical performance study planning, operations and analysis for product-specific FDA or European submission requirements.
Project Management
HMC supports clinical study sponsors with study plans, coordination and progress reporting. Project responsibilities and documentation are aligned with the study protocol and applicable good clinical practice (GCP) requirements.
Clinical Operations
HMC supports clinical study sponsors with site start-up, monitoring and study-document coordination under applicable good clinical practice (GCP) requirements. Work includes trial master file (TMF) and informed consent form (ICF) documentation where specified.
Data Management
HMC supports clinical study sponsors with data management plans, case report forms (CRFs), data review and database-lock preparation. Work follows the study protocol and applicable data standards.
Biostatistics
HMC supports study teams with sample-size planning, statistical analysis plans and reporting. For diagnostic studies, analysis may address sensitivity and specificity against the study protocol and intended submission requirements.
Quality Assurance
HMC supports clinical study teams with process assessments, audit planning and documentation of findings. The review scope follows the study requirements and applicable good clinical practice (GCP) standards.
Preclinical Research
HMC supports developers with preclinical study planning and laboratory selection for product-specific FDA evaluation requirements. Study scope and laboratory responsibilities are confirmed for each engagement.
Clinical investigation.
HMC supports pharmaceutical sponsors with clinical trial planning, management and analysis for regulatory submissions. The study scope is defined by the development program, protocol and applicable clinical investigation requirements.
IVD & Device Compliance
OTC Drug
HMC supports over-the-counter (OTC) drug companies with FDA establishment registration, product listing and submission documentation, including structured product labeling (SPL). The applicable requirements depend on the product.
Product Development
HMC supports medical technology companies with product development planning and evidence requirements for the intended market. Regulatory preparation is scoped to the product and its proposed submission route.
Post Market Surveillance
HMC supports medical device companies with post-market surveillance plans and risk-management work under applicable US and European requirements. Activities are scoped to the product, market and existing quality management system.
Food and Dietary Supplements
HMC supports food and dietary supplement businesses with FDA facility registration, labeling review and applicable import requirements, including Foreign Supplier Verification Programs (FSVP). Scope depends on the product and business role.
CGMP
HMC supports manufacturers with current good manufacturing practice (CGMP) audits and quality-system review. For medical devices, FDA requirements include the Quality Management System Regulation (QMSR) in 21 CFR Part 820.
European IVDR
HMC supports in vitro diagnostic manufacturers with technical documentation and quality-system planning under the European In Vitro Diagnostic Medical Devices Regulation (IVDR). The work supports applicable conformity assessment and CE marking preparation.
Post Market Compliance
HMC supports life science companies responding to FDA inspection observations and warning letters. Work includes corrective-action planning and documentation review for the applicable product and quality requirements.
Quality Systems
HMC supports medical device companies with quality management system documentation under FDA QMSR, 21 CFR Part 820 and ISO 13485, as applicable. Scope includes assessment, action planning and supporting records.
FDA Regulatory Consulting
Regulatory Strategy
HMC helps medical device companies assess FDA submission options, including 510(k), investigational device exemption (IDE) and other product-specific routes. Review includes intended use, technology and the availability of a predicate device.
Regulatory Submission
HMC supports medical technology companies preparing FDA and European submission materials. Scope may include 510(k), Emergency Use Authorization (EUA) or In Vitro Diagnostic Medical Devices Regulation (IVDR) documentation, according to the product and applicable pathway.
Facility Registration and Listing
HMC supports medical device and IVD establishments with FDA establishment registration and device listing. These administrative requirements are distinct from product-specific premarket clearance or approval.
FDA US Agent
HMC offers FDA US agent support for foreign establishments and assistance with registration-related communication. The applicable appointment and registration requirements depend on the establishment and product category.
Medical Device 510(k)
HMC supports medical device companies preparing FDA 510(k) premarket notifications and related regulatory documentation. The submission route and evidence requirements depend on the device and its intended use.
EUA Application
HMC supports developers preparing Emergency Use Authorization (EUA) materials for medical products. Eligibility, submission scope and authorization depend on the applicable FDA emergency framework.
FDA Regulatory Consulting
HMC supports medical product companies with FDA development planning and submission preparation. Services are scoped to the product and applicable pathway, including 510(k), De Novo, premarket approval (PMA) or Emergency Use Authorization (EUA).
Laboratory Services
Laboratory Services
HMC coordinates laboratory support for diagnostic projects through associated businesses and partners. The laboratory provider, validation scope and applicable quality requirements are confirmed for each engagement.
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PROJECTS
Practical support for your next step.
Explore the full range of project services, from EUA applications and 510(k) submissions to a US sales presence.
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