AlvaMed, LLC
Industry: Company
DescriptionFounded: 2003
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AlvaMed, LLC Employees
Employee
Years
Job
Industry
William Hassel William Hassel's AlvaMed, LLC Experience 2005 - 2010
Job Medical Device Consultant, 30 years experience: design, compliance, quality, risk management, regulatory
Industry Medical Devices
Experience
Depuy Synthes - Johnson & Johnson July 2013 - Present
Project MedTech, Inc. 1998 - Present
Terumo Cardiovascular Systems May 2013 - July 2013
Terumo Heart, Inc. November 2010 - December 2012
MRC, Inc. July 2010 - August 2011
AlvaMed, LLC 2005 - 2010
Baxter Healthcare 2006 - 2009
QPharma, Inc. 2003 - 2006
Quintiles Consutling December 1988 - June 1999
Aastrom Biosciences 1994 - 1998
Skills
FDA, CAPA, Validation, Medical Devices, ISO 13485, Quality System, Quality Assurance, GMP, V&V, Regulatory Affairs, Cross-functional Team..., R&D, Biotechnology, Design Control, Testing, Engineering, Commercialization, Product Launch, ISO 14971, Manufacturing, Product Development, Quality Management, Risk Management, Quality Control, FMEA, Software Documentation, Lifesciences, Clinical Trials, Technology Transfer, Biomedical Engineering, Regulatory Requirements, Root Cause Analysis, Regulatory Submissions, Computer System..., Six Sigma, Clinical Development, Quality Auditing, ISO, 21 CFR Part 11, Change Control, GxP, Process Simulation, Sop, Electrical Engineering, 60601-1 3rd Edition, Functional Requirements, Requirements Management, Requirements...
Education
Rutgers University-New Brunswick
BA, English
University of Miami
MSBE, Biomedical Engineering
Vanderbilt University
Electrical and Biomedical Engineering
Depuy Synthes - Johnson & Johnson July 2013 - Present
Project MedTech, Inc. 1998 - Present
Terumo Cardiovascular Systems May 2013 - July 2013
Terumo Heart, Inc. November 2010 - December 2012
MRC, Inc. July 2010 - August 2011
AlvaMed, LLC 2005 - 2010
Baxter Healthcare 2006 - 2009
QPharma, Inc. 2003 - 2006
Quintiles Consutling December 1988 - June 1999
Aastrom Biosciences 1994 - 1998
Skills
FDA, CAPA, Validation, Medical Devices, ISO 13485, Quality System, Quality Assurance, GMP, V&V, Regulatory Affairs, Cross-functional Team..., R&D, Biotechnology, Design Control, Testing, Engineering, Commercialization, Product Launch, ISO 14971, Manufacturing, Product Development, Quality Management, Risk Management, Quality Control, FMEA, Software Documentation, Lifesciences, Clinical Trials, Technology Transfer, Biomedical Engineering, Regulatory Requirements, Root Cause Analysis, Regulatory Submissions, Computer System..., Six Sigma, Clinical Development, Quality Auditing, ISO, 21 CFR Part 11, Change Control, GxP, Process Simulation, Sop, Electrical Engineering, 60601-1 3rd Edition, Functional Requirements, Requirements Management, Requirements...
Education
Rutgers University-New Brunswick
BA, English
University of Miami
MSBE, Biomedical Engineering
Vanderbilt University
Electrical and Biomedical Engineering
Martin Sklar Martin Sklar's AlvaMed, LLC Experience February 2002 - December 2006
Job President, CEO and Founder AblaCor Medical Corporation ("Ablacor" or "AMC")
Industry Medical Devices
Experience
AblaCor Medical Corporation February 1992 - Present
Automated Medical Instruments 2004 - 2014
Thoratec June 2010 - November 2010
Medical Development Partners, LLC. January 2005 - August 2008
Medical Development Group 2004 - 2007
AlvaMed, LLC February 2002 - December 2006
Biowave 2002 - 2005
Biovalve (now Valeritas) April 2002 - November 2003
Visualization Technology, Inc. (VTI) sold to GE Healthcare August 1997 - August 2001
Dade Behring 1996 - 1997
Skills
Entrepreneurship, Analysis, FMEA, Intellectual Property, CAD, Research, Risk Analysis, Medical Device Project..., Medical Devices, R&D, Medical Device R&D, Product Development, Start-ups, Biomedical Engineering, Commercialization, Cross-functional Team..., Biotechnology, Strategy, Project Management, Business Development, Marketing, Engineering, Management, Manufacturing, Regulations, Engineers, Lifesciences, FDA, Product Launch, Business Strategy, Clinical Research, Mergers & Acquisitions
Education
Dartmouth College, Thayer School of Engineering 1974 — 1977
Master Of Engineering
Worcester Polytechnic Institute 1969 — 1974
Bachelor of Science in Mechancial Engineering
Boston Latin School 1963 — 1969
High School
AblaCor Medical Corporation February 1992 - Present
Automated Medical Instruments 2004 - 2014
Thoratec June 2010 - November 2010
Medical Development Partners, LLC. January 2005 - August 2008
Medical Development Group 2004 - 2007
AlvaMed, LLC February 2002 - December 2006
Biowave 2002 - 2005
Biovalve (now Valeritas) April 2002 - November 2003
Visualization Technology, Inc. (VTI) sold to GE Healthcare August 1997 - August 2001
Dade Behring 1996 - 1997
Skills
Entrepreneurship, Analysis, FMEA, Intellectual Property, CAD, Research, Risk Analysis, Medical Device Project..., Medical Devices, R&D, Medical Device R&D, Product Development, Start-ups, Biomedical Engineering, Commercialization, Cross-functional Team..., Biotechnology, Strategy, Project Management, Business Development, Marketing, Engineering, Management, Manufacturing, Regulations, Engineers, Lifesciences, FDA, Product Launch, Business Strategy, Clinical Research, Mergers & Acquisitions
Education
Dartmouth College, Thayer School of Engineering 1974 — 1977
Master Of Engineering
Worcester Polytechnic Institute 1969 — 1974
Bachelor of Science in Mechancial Engineering
Boston Latin School 1963 — 1969
High School
Ellen Golds Ellen Golds's AlvaMed, LLC Experience August 2003 - June 2008
Job Owner, Golds Associates, LLC
Industry Medical Devices
Experience
Golds Associates, LLC 2001 - Present
Validant June 2011 - January 2012
AlvaMed, LLC August 2003 - June 2008
Renaltech 2000 - 2000
Boston Scientific Corp. 1997 - 2000
Datascope 1996 - 1997
US Surgical Corp 1992 - 1996
Baxter Healthcare 1984 - 1990
American Medical Systems September 1978 - September 1984
Skills
Project Management, Medical Device Product..., Medical Devices, Quality Systems, Product Development, Design Control, MS Project, Project Planning, Project Implementation, Program Management, Project Portfolio..., Expert Witness, Quality System, FDA, CAPA, R&D, GMP, Cross-functional Team..., Validation, Quality Management, 21 CFR Part 11, Pharmaceutical Industry, V&V, Quality Assurance, Commercialization, ISO 13485, ISO 14971, Manufacturing, Regulatory Affairs
Education
Northwestern University 1974 — 1978
BS BME
Golds Associates, LLC 2001 - Present
Validant June 2011 - January 2012
AlvaMed, LLC August 2003 - June 2008
Renaltech 2000 - 2000
Boston Scientific Corp. 1997 - 2000
Datascope 1996 - 1997
US Surgical Corp 1992 - 1996
Baxter Healthcare 1984 - 1990
American Medical Systems September 1978 - September 1984
Skills
Project Management, Medical Device Product..., Medical Devices, Quality Systems, Product Development, Design Control, MS Project, Project Planning, Project Implementation, Program Management, Project Portfolio..., Expert Witness, Quality System, FDA, CAPA, R&D, GMP, Cross-functional Team..., Validation, Quality Management, 21 CFR Part 11, Pharmaceutical Industry, V&V, Quality Assurance, Commercialization, ISO 13485, ISO 14971, Manufacturing, Regulatory Affairs
Education
Northwestern University 1974 — 1978
BS BME
David Manalan David Manalan's AlvaMed, LLC Experience 2011 - September 2014
Job Senior FDA and Quality SystemsConsultant
Industry Medical Devices
Experience
INQC Consulting, Inc. January 1992 - Present
ASQ Biomedical Division 1995 - Present
AlvaMed, LLC 2011 - September 2014
ASQ Boston Section September 2008 - May 2011
MassExcellence April 2009 - April 2011
CLSI 2009 - 2011
Ken Block Consulting 2009 - 2010
Barile-Consulting 2007 - 2010
American Society for Quality- FDC 2001 - 2010
SoftwareCPR 2000 - 2009
Skills
ISO 13485, ISO 14971, Quality Systems, FDA, CAPA, CQA, Quality Assurance, Auditing, Pharmaceuticals, Medical Devices, Validation, Process Validation, Quality Auditing, Biomedical Auditing, Teaching Adults, Quality System, V&V, Sustainability, Risk Management, Risk Assessment, Enterprise Risk..., GMP, Pharmaceutical Industry, Regulatory Affairs, Root Cause Analysis, Design Control, Manufacturing, Training, Quality Management, Program Management, Process Improvement, Six Sigma, ISO, Cross-functional Team..., Iso 9000, Sop, 21 CFR Part 11, TQM, Biomedical Engineering, Process Engineering, Change Control, Design of Experiments, R&D, Lean Manufacturing, Continuous Improvement, Biotechnology, SPC, DMAIC, Quality Control, FMEA
Education
Massachusetts Institute of Technology 1961 — 1965
BS, Chem Eng
INQC Consulting, Inc. January 1992 - Present
ASQ Biomedical Division 1995 - Present
AlvaMed, LLC 2011 - September 2014
ASQ Boston Section September 2008 - May 2011
MassExcellence April 2009 - April 2011
CLSI 2009 - 2011
Ken Block Consulting 2009 - 2010
Barile-Consulting 2007 - 2010
American Society for Quality- FDC 2001 - 2010
SoftwareCPR 2000 - 2009
Skills
ISO 13485, ISO 14971, Quality Systems, FDA, CAPA, CQA, Quality Assurance, Auditing, Pharmaceuticals, Medical Devices, Validation, Process Validation, Quality Auditing, Biomedical Auditing, Teaching Adults, Quality System, V&V, Sustainability, Risk Management, Risk Assessment, Enterprise Risk..., GMP, Pharmaceutical Industry, Regulatory Affairs, Root Cause Analysis, Design Control, Manufacturing, Training, Quality Management, Program Management, Process Improvement, Six Sigma, ISO, Cross-functional Team..., Iso 9000, Sop, 21 CFR Part 11, TQM, Biomedical Engineering, Process Engineering, Change Control, Design of Experiments, R&D, Lean Manufacturing, Continuous Improvement, Biotechnology, SPC, DMAIC, Quality Control, FMEA
Education
Massachusetts Institute of Technology 1961 — 1965
BS, Chem Eng
Brian Connolly Brian Connolly's AlvaMed, LLC Experience March 2010 - January 2011
Job
Industry Medical Devices
Experience
Medtronic February 2015 - Present
Lantos Technologies June 2013 - December 2014
Farm Design, Inc. January 2011 - March 2013
AlvaMed, LLC March 2010 - January 2011
First Light Biosciences September 2008 - April 2010
Teleflex Medical May 2004 - July 2008
Abbott Laboratories/MediSense Products June 2000 - May 2004
Agilent Technologies December 1999 - May 2000
Hewlett Packard 1984 - 2000
Skills
Product Management, Change Management, Business Strategy, Start-ups, Leadership, Outsourcing, Business Planning, Medical Devices, FDA, Design Control, ISO 13485, Product Development, V&V, Cross-functional Team..., ISO, Validation, Process Improvement, Product Lifecycle..., Analytics, Labview, Engineering, Design for Manufacturing, ISO 14971, Continuous Improvement, Testing, Engineering Management, Product Launch, Embedded Systems, Process Engineering, Lean Manufacturing, Manufacturing, R&D, Biomedical Engineering, Commercialization, Quality System, Manufacturing..., Medical Device R&D, Product Design, CAPA, Medical Imaging, Solidworks, Design of Experiments, Management, Systems Engineering, Quality Assurance, Process Simulation, Strategic Planning, Electronics, Six Sigma, Strategy
Education
Loyola University Maryland 1981 — 1983
MES, Digital Systems
Loyola University Maryland 1973 — 1977
BS, Physics/Engineering
Medtronic February 2015 - Present
Lantos Technologies June 2013 - December 2014
Farm Design, Inc. January 2011 - March 2013
AlvaMed, LLC March 2010 - January 2011
First Light Biosciences September 2008 - April 2010
Teleflex Medical May 2004 - July 2008
Abbott Laboratories/MediSense Products June 2000 - May 2004
Agilent Technologies December 1999 - May 2000
Hewlett Packard 1984 - 2000
Skills
Product Management, Change Management, Business Strategy, Start-ups, Leadership, Outsourcing, Business Planning, Medical Devices, FDA, Design Control, ISO 13485, Product Development, V&V, Cross-functional Team..., ISO, Validation, Process Improvement, Product Lifecycle..., Analytics, Labview, Engineering, Design for Manufacturing, ISO 14971, Continuous Improvement, Testing, Engineering Management, Product Launch, Embedded Systems, Process Engineering, Lean Manufacturing, Manufacturing, R&D, Biomedical Engineering, Commercialization, Quality System, Manufacturing..., Medical Device R&D, Product Design, CAPA, Medical Imaging, Solidworks, Design of Experiments, Management, Systems Engineering, Quality Assurance, Process Simulation, Strategic Planning, Electronics, Six Sigma, Strategy
Education
Loyola University Maryland 1981 — 1983
MES, Digital Systems
Loyola University Maryland 1973 — 1977
BS, Physics/Engineering
David Ennen's AlvaMed, LLC Experience January 2012 - Present
Job Medical Device Professional Software, Systems, Process, Risk
Industry Medical Devices
Experience
RSQM Associates LLC June 2014 - Present
NN Medical February 2012 - Present
AlvaMed, LLC January 2012 - Present
Oxford International July 2011 - Present
Skills
FDA, ASEAN, Product Development, Process Development, Design Control, Software Engineering, Embedded Systems, Systems Engineering, Risk Management, CE marking, Formal Verification, Requirements Management, Medical Devices, System Design, 60601-1 3rd Edition, ISO 14971, Submittals, Lifesciences, V&V, IEC 60601, Process Simulation, R&D, Testing, Validation, Quality Assurance, Quality System, Cross-functional Team..., Computer System..., 21 CFR Part 11, Commercialization, Regulatory Affairs, GMP, Biomedical Engineering, Change Control, Design of Experiments, FMEA, Quality Auditing, ISO, Quality Management, ISO 13485, GxP, IEC 62304, Technology Transfer, Regulatory Submissions, Six Sigma, Quality Control, Root Cause Analysis, Life Sciences
Education
University of Michigan 1976 — 1978
M.S.
University of Cincinnati 1971 — 1974
B.S.
St. John's
RSQM Associates LLC June 2014 - Present
NN Medical February 2012 - Present
AlvaMed, LLC January 2012 - Present
Oxford International July 2011 - Present
Skills
FDA, ASEAN, Product Development, Process Development, Design Control, Software Engineering, Embedded Systems, Systems Engineering, Risk Management, CE marking, Formal Verification, Requirements Management, Medical Devices, System Design, 60601-1 3rd Edition, ISO 14971, Submittals, Lifesciences, V&V, IEC 60601, Process Simulation, R&D, Testing, Validation, Quality Assurance, Quality System, Cross-functional Team..., Computer System..., 21 CFR Part 11, Commercialization, Regulatory Affairs, GMP, Biomedical Engineering, Change Control, Design of Experiments, FMEA, Quality Auditing, ISO, Quality Management, ISO 13485, GxP, IEC 62304, Technology Transfer, Regulatory Submissions, Six Sigma, Quality Control, Root Cause Analysis, Life Sciences
Education
University of Michigan 1976 — 1978
M.S.
University of Cincinnati 1971 — 1974
B.S.
St. John's
Lou Cabana's AlvaMed, LLC Experience March 2008 - May 2013
Job Medical Devices Consultant
Industry Medical Devices
Experience
AccuNostics Ltd October 2013 - Present
AlvaMed, LLC March 2008 - May 2013
Goldman-Collins 2011 - 2012
Xhale Diagnostics 2009 - 2011
Xhale Diagnotics January 2009 - February 2010
Jack Conway & Co., Inc. 2010 - 2010
LRC Consultancy 2007 - 2008
Lifescan Scotland a J&J company 2005 - 2007
LifeScan, a Johnson & Johnson Company January 2002 - December 2004
Inverness Medical June 2001 - January 2002
Skills
Strategic Leadership, Tactical Implementation, Operational Excellence, Medical Devices, Commercialization, Diagnostics, Technology Transfer, Product Launch, Hardware Diagnostics, Program Management, FDA, Cross-functional Team..., Supply Chain, Product Development, ISO 13485, Product Management, Validation, Manufacturing, CAPA, Quality System, R&D, Design Control, GMP, V&V, Start-ups, Biotechnology, Pharmaceutical Industry, Market Development, Business Development, Six Sigma, Biopharmaceuticals, Quality Assurance, 21 CFR Part 11, Quality Auditing, Global Marketing, Change Control, Lifesciences, Clinical Development, Computer System..., Regulatory Submissions, GLP, Clinical Trials, Oncology, Process Simulation, Drug Development, Regulatory Requirements, Life Sciences
Education
Worcester Polytechnic Institute 1982 — 1985
MBA, Technical management and International Business
Northeastern University 1972 — 1975
MS, Medicinal Chemistry
St. John Fisher College 1965 — 1969
BS, Chemistry and Biology
AccuNostics Ltd October 2013 - Present
AlvaMed, LLC March 2008 - May 2013
Goldman-Collins 2011 - 2012
Xhale Diagnostics 2009 - 2011
Xhale Diagnotics January 2009 - February 2010
Jack Conway & Co., Inc. 2010 - 2010
LRC Consultancy 2007 - 2008
Lifescan Scotland a J&J company 2005 - 2007
LifeScan, a Johnson & Johnson Company January 2002 - December 2004
Inverness Medical June 2001 - January 2002
Skills
Strategic Leadership, Tactical Implementation, Operational Excellence, Medical Devices, Commercialization, Diagnostics, Technology Transfer, Product Launch, Hardware Diagnostics, Program Management, FDA, Cross-functional Team..., Supply Chain, Product Development, ISO 13485, Product Management, Validation, Manufacturing, CAPA, Quality System, R&D, Design Control, GMP, V&V, Start-ups, Biotechnology, Pharmaceutical Industry, Market Development, Business Development, Six Sigma, Biopharmaceuticals, Quality Assurance, 21 CFR Part 11, Quality Auditing, Global Marketing, Change Control, Lifesciences, Clinical Development, Computer System..., Regulatory Submissions, GLP, Clinical Trials, Oncology, Process Simulation, Drug Development, Regulatory Requirements, Life Sciences
Education
Worcester Polytechnic Institute 1982 — 1985
MBA, Technical management and International Business
Northeastern University 1972 — 1975
MS, Medicinal Chemistry
St. John Fisher College 1965 — 1969
BS, Chemistry and Biology
Rosalyn Yang's AlvaMed, LLC Experience 2005 - 2008
Job Medical Device and Pharmaceutical Industry Consultant
Industry Medical Devices
Experience
Quality Systems and Compliance (QSC) January 2012 - Present
QPharma, Inc. 2008 - 2011
AlvaMed, LLC 2005 - 2008
Bio-Chem Valve Inc. 1997 - 2000
Fresenius Medical Care 1996 - 1997
Whatman 1994 - 1996
iSTAT Corporation 1994 - 1994
Boston VA Medical Center 1993 - 1994
The General Hospital Center at Passaic 1987 - 1993
Skills
Medical Devices, Quality Systems, CAPA, Documentation, ISO 13485
Education
Boston University
BS, Biomedical Engineering
Passaic High School
Quality Systems and Compliance (QSC) January 2012 - Present
QPharma, Inc. 2008 - 2011
AlvaMed, LLC 2005 - 2008
Bio-Chem Valve Inc. 1997 - 2000
Fresenius Medical Care 1996 - 1997
Whatman 1994 - 1996
iSTAT Corporation 1994 - 1994
Boston VA Medical Center 1993 - 1994
The General Hospital Center at Passaic 1987 - 1993
Skills
Medical Devices, Quality Systems, CAPA, Documentation, ISO 13485
Education
Boston University
BS, Biomedical Engineering
Passaic High School
Richelle Helman's AlvaMed, LLC Experience 2004 - 2006
Job Regulatory Manager at Vapotherm
Industry Medical Devices
Experience
Vapotherm November 2013 - Present
Richelle Helman Consulting May 1999 - Present
NeuroTherm, Inc. March 2013 - November 2013
Teleflex September 2010 - November 2012
AlvaMed, LLC 2004 - 2006
UroMed Corporation 1995 - 1998
USCI 1987 - 1995
Skills
Design Control, Medical Devices, Regulatory Affairs, Product Development, ISO 13485, FDA, Quality System, V&V, Validation, Biomedical Engineering, R&D, ISO 14971, Commercialization, Cross-functional Team..., CAPA, FMEA, Product Launch, Quality Assurance
Education
Northeastern University 2006 — 2008
Graduate Certificate, Medical Devices RA
D'Amore-McKim School of Business at Northeastern University 1993 — 1995
MBA, High Technology
Boston University 1985 — 1987
MS, Biomedical Engineering
Union College 1981 — 1985
BS, Mechanical Engineering
Vapotherm November 2013 - Present
Richelle Helman Consulting May 1999 - Present
NeuroTherm, Inc. March 2013 - November 2013
Teleflex September 2010 - November 2012
AlvaMed, LLC 2004 - 2006
UroMed Corporation 1995 - 1998
USCI 1987 - 1995
Skills
Design Control, Medical Devices, Regulatory Affairs, Product Development, ISO 13485, FDA, Quality System, V&V, Validation, Biomedical Engineering, R&D, ISO 14971, Commercialization, Cross-functional Team..., CAPA, FMEA, Product Launch, Quality Assurance
Education
Northeastern University 2006 — 2008
Graduate Certificate, Medical Devices RA
D'Amore-McKim School of Business at Northeastern University 1993 — 1995
MBA, High Technology
Boston University 1985 — 1987
MS, Biomedical Engineering
Union College 1981 — 1985
BS, Mechanical Engineering
Bryan Martin's AlvaMed, LLC Experience 2010 - 2011
Job Director of Quality Assurance at RTI Biologics
Industry Medical Devices
Experience
RTI Biologics 2011 - Present
AlvaMed, LLC 2010 - 2011
Edwards Lifesciences 2010 - 2011
CardioDx 2009 - 2010
Ortho Development 2005 - 2009
Maxtec Inc 2004 - 2005
Pathway Medical 2003 - 2004
Zimmer 2002 - 2004
Sulzer 2002 - 2004
Centerpulse 2002 - 2004
Skills
Quality Assurance, Medical Devices, Product Development, Manufacturing, Engineering, FDA, ISO 13485, CAPA, Quality System, Design Control, V&V, Validation, Quality Control, Regulations, Regulatory Affairs, Start-ups, GMP, Orthopedic, Quality Management, Change Control, Sop, Cross-functional Team..., R&D, Sales, Biotechnology, Product Launch, Root Cause Analysis, Project Management, 21 CFR Part 11, Quality Auditing, Capital Equipment, Commercialization, Orthopedics
Education
Westminster College of Salt Lake City 1997 — 1999
MBA, Business / Marketing
Brigham Young University 1992 — 1997
BS, Mechanical & Manufacturing Eng
RTI Biologics 2011 - Present
AlvaMed, LLC 2010 - 2011
Edwards Lifesciences 2010 - 2011
CardioDx 2009 - 2010
Ortho Development 2005 - 2009
Maxtec Inc 2004 - 2005
Pathway Medical 2003 - 2004
Zimmer 2002 - 2004
Sulzer 2002 - 2004
Centerpulse 2002 - 2004
Skills
Quality Assurance, Medical Devices, Product Development, Manufacturing, Engineering, FDA, ISO 13485, CAPA, Quality System, Design Control, V&V, Validation, Quality Control, Regulations, Regulatory Affairs, Start-ups, GMP, Orthopedic, Quality Management, Change Control, Sop, Cross-functional Team..., R&D, Sales, Biotechnology, Product Launch, Root Cause Analysis, Project Management, 21 CFR Part 11, Quality Auditing, Capital Equipment, Commercialization, Orthopedics
Education
Westminster College of Salt Lake City 1997 — 1999
MBA, Business / Marketing
Brigham Young University 1992 — 1997
BS, Mechanical & Manufacturing Eng
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