WHO
WE
A R E
We are a team of professionals with experience in both academia and industry. With PhDs and postdoctoral background in various biomedical disciplines and data sciences, we offer you our gamut of expertise in medical writing & communication, clinical trial management, clinical evaluation, FDA/EU regulations for medical devices, and Big-Data oriented thinking in biomedical research.
Although we represent a cross-section of professional skill sets and experience, each of us believes in delivering superior service. Our sole focus is on making our clients’ businesses run as successfully as possible. We look forward to serving your needs as best as we can.
WHAT
WE
D E L I V E R
FDA and EU SUBMISSIONS
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IDE and 510k
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Clinical Evaluation Report (CER) in accordance with MedDev 2.7/1 Rev.4 and updated MDR Guidelines
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CERs for Class I, II and III devices, for initial certification, recertification or annual update
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Post Market Surveillance (PMS) Plan and Post Market Clinical Follow-Up (PMCF) Plan
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Gap Analysis for CERs, PMS, and PMCF
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Clinical trial Design for PMCF studies
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In-depth Risk/Benefit Analysis
CLINICAL TRIALS
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Feasibility
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Site Selection and Start-up
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Clinical Trial protocols for both US and EU
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Investigator’s brochure
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Post-Approval activities including annual reports and safety reporting
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Clinical Study reports, Phases I-IV
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Labeling
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Patient narratives
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Informed Consent/Assents
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Electronic Data Management
SCIENTIFIC COMMUNICATION
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Grant and manuscript writing
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Science articles for the lay audience
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Content management: writing and maintaining Blogs
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Content management: Running Podcasts
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Science education: lectures and presentation
DIGITAL HEALTH
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Research and review trends in innovative Health Technologies
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Recommendations for Premarket Review and PMS
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Digital Health focus for machine learning/AI/Big Data/Advanced Analytics
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Application of existing digital health policies
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Review risk/benefit of Digital health products
QUALITY MANAGEMENT SYSTEM
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Creation and maintenance of Standard Operating Procedures (SOPs)
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Creation and maintenance of Work Instruction (WI)
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Review of compliance with MedDev 2.7/1 Rev. 4 and EU Regulation 2017/745
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Review and appraisal of Risk Management processes (including PMS and PMCF)
We deliver professionalism with a heart.
GET
IN
T O U C H
Questions? Write to us below
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