Qserve Spotlight on US Team

Qserve Group is pleased to announce that we have expanded our US team of consultants in response to the growing demand for worldwide Regulatory, Quality and Clinical support, including MDR/IVDR related projects. Expanding our team allows us to support our global clients, including US manufacturers, as they adapt to the changing regulatory and compliance landscape in Europe, North America and China by providing RA/QA/CA strategy and execution for their new product development and sustaining product portfolios.

Our areas of expertise now include:

Regulatory Affairs

MDD/AIMD/IVDD, MDR/IVDR
US submissions (510k, PMA, IDE etc.)
License applications for China, Japan, and Canada
Classification, technical documentation, regulatory strategy, and practical industry experience

Product Registration  

Local approvals in 40+ countries to date using our network of global partners
US team supported by Global Registration manager

Clinical Affairs

MEDDEV 2.7/1 rev 4 
MDR/IVDR clinical expectations from a Notified Body’s perspective
Writing CEP/CERs and literature retrieval for all device classifications
Gap analyses to MEDDEV, MDR/IVDR clinical requirements, PMS/PMCF, and labeling
Biostatistics and study design, method development for devices and diagnostics 
Clinical trial design, data management, and sample size/power analysis

Quality Affairs

Hands on experience in designing and operating QMS for the medical device and IVD industries
Extensive QMS expertise, including the IT systems which support QMS
Successful delivery of quality engineering results
State of the art QMS, best practices, and Software experience (e.g. EN 62304)
Program/Project Management to support business, product or project initiatives (e.g. MDR/IVDR, new product development)

Training

EU MDR/IVDR,
ISO 13485: 2016, MDSAP, QSR/GMP
Risk Management
Clinical requirements
Lead Auditor/Internal Auditor


Please check here our MedTech Training Program 2018-2019


Auditing

Internal Audit including
MDD/MDR, AIMD, IVDD/IVDR, MDSAP, ISO 13485(2003/2016)
QSIT/QSR
Supplier audits, including those needed for clinical investigation execution
“Mock” third party audits
MDD/AIMD/IVDD
MDR/IVDR
MDSAP, QSR
ISO 13485 


For further information, please visit our website: www.qservegroup.com, or contact our US office manager Jennifer Hadfield, at jennifer.hadfield@qservegroup.com.  


US Staff:

Dr. Keith Morel, VP Regulatory Compliance (Regulatory, Quality, Clinical)
Mindy McCann, VP Regulatory Compliance (Regulatory, Quality, Clinical)
Adriana Becker, Regulatory Affairs & Clinical Expert
Mari Leong, Regulatory Affairs & Clinical Expert 
Tran Do, QA, Program Management & Regulatory Intelligence Expert
Jasmin Hunter, Clinical & Regulatory Affairs Expert 
Rania Gerges, QA and Statistics Expert 
Lorry Huffman, Regulatory Affairs/Clinical/IVD Expert
Patsy Trisler, FDA Expert 
Jennifer Hadfield, US Office Manager, US Agent Services 
Leonard Buchner, Statistics, Regulatory and Clinical Expert for IVD
Gene Redig, QA, Auditing and Software Expert
Christie Hughes, Regulatory and Quality IVD Expert


Meet our Qserve team at the RAPS Regulatory Convergence 2018!


Your Global Medtech Partner for Clinical, Quality, & Regulatory Compliance

 


 

 


 

Profiles:

Adriana Becker
Rania Gerges
Jennifer Hadfield
Jasmin Hunter
Mari Leong
Mindy McCann
Keith Morel
Patsy Trisler
Lorry Weaver Huffman
Tran Do
Post date: September 03, 2018
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