Patrick Balsmann Email and Phone Number
Patrick Balsmann work email
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Patrick Balsmann personal email
I have been responsible for developing the regulatory/clinical and quality assurance strategies for Bonutti Technologies. Bonutti Technologies is an incubator for new ideas in surgical instrumentation, implants, procedures, and rehabilitation. It's founder and my boss, Dr. Peter Bonutti MD is an orthopedic surgeon and inventor with over 450 patents and 730 licenses with 25 medical device companies. Dr. Bonutti is the founder of Bonutti Technologies, Joint Active Systems, AxioSonic, Multitak, and OsteoWeld medical device companies.
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Director Regulatory And Clinical Affairs And QaRealeve LlcEffingham, Il, Us
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Director Regulatory/Clinical Affairs & QaRealeve Llc Jan 2020 - Present
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Director Regulatory/Clinical Affairs & QaJoint Active Systems (Jas) Jan 1998 - Present -
Director Regulatory/Clinical Affairs & QaBonutti Technologies, Inc 1998 - PresentBonutti Technologies is FDA registered and I have been responsible for multiple FDA 510(k)s including orthopedic sports medicine implants (e.g., suture anchors & trauma fixation devices). Products included the first allograft suture anchor cleared by the FDA and tissue fixation biodegradable implant devices involving our novel ultrasonic technology. Recent development projects have included FDA 510(k) clearance for our JAS Pulse Ultrasonic Therapy Device. The JAS Pulse is an ultrasound diathermy device that will be distributed by Joint Active Systems (JAS). I am responsible for all RA/QA & Clinical development for JAS including FDA and international registrations.AxioSonic has just completed a clinical trial and a Pre-Submission meeting with FDA. -
Director Regulatory/Clinical Affairs & QaAxiosonic Jan 2015 - Dec 2019I have coordinated development of the clinical trial for our AxioSonic ultrasonic device used to treat chronic sinusitis. This has included writing of the protocol & developing case report forms, presentations to the IRB, and the monitoring of the study with the principal investigator. -
Regulatory Clinical Affairs / Cell Biology ResearchStorz Instrument (Now Part Of Bausch & Lomb) Jan 1993 - Dec 1997Greater St. Louis AreaStorz Instrument is a leading ophthalmic medical device company that is now part of Bausch & Lomb. While at Storz I ventured out of the cell biology lab and became involved in clinical research and regulatory affairs. This included:- Prepared 510(k)s for phacoemulsification ultrasound systems & disposable accessories- Coordinated cross-functional FDA pre-submission meeting at FDA for novel glaucoma device. - Managed clinical investigator meeting of 15 cataract surgeons for intraocular lens (IOL) IDE.- Prepared & managed IDE cochlear implant close-out including patient follow-up & termination offer.- Prepared IDE/PMA sections related to clinical trials for PMA submissions- Supervised cell biology lab including personnel & development of histology & biochemical techniques.
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Senior Cell Culture ScientistInvitron Corporation Aug 1987 - Nov 1990Greater St. Louis AreaInvitron Corporation was a biotech pharmaceutical company using proprietary continuous flow bioreactor technology to manufacture cell-secreted proteins. While at Invitron I:- Designed & performed cell biology experiments involving genetically engineered cell lines for potential therapeutics.- Developed & performed metabolic biochemical testing including HPLC and ELISA techniques.
Patrick Balsmann Skills
Patrick Balsmann Education Details
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Master Of Business Administration (Mba) -
Cell/Cellular And Molecular Biology -
Zoology/Animal Biology
Frequently Asked Questions about Patrick Balsmann
What company does Patrick Balsmann work for?
Patrick Balsmann works for Realeve Llc
What is Patrick Balsmann's role at the current company?
Patrick Balsmann's current role is Director Regulatory and Clinical Affairs and QA.
What is Patrick Balsmann's email address?
Patrick Balsmann's email address is pa****@****rch.com
What schools did Patrick Balsmann attend?
Patrick Balsmann attended University Of St. Francis, Southeast Missouri State University, Southeast Missouri State University, Southeast Missouri State University, Southeast Missouri State University.
What skills is Patrick Balsmann known for?
Patrick Balsmann has skills like Quality System, Quality Management, U.s. Food And Drug Administration, Medical Devices, Cross Functional Team Leadership, Product Development, Iso Standards, Fda, Iso 13485, Regulatory Affairs, Validation, Manufacturing.
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