Founded in 2018 by Mike Bravo, our goal is to blend our preclinical/R&D backgrounds (surgical/interventional procedural support, engineering team interactions, science and design of studies) with our multifunctional team experiences (regulatory, clinical, biostats, etc.) to help clients drive their progress in a very efficient and forward thinking manner.
Product Development/R&D Support:
Evaluation/vetting of devices from pre-prototype (physiologic theory) thru GLP
Data generation strategies for fund raising or go/no-go
Multifunctional/multidisciplinary developmental strategy formation and execution (R&D, regulatory, clinical, quality perspectives)
Study design
Surgical and Interventional Support (animal, human cadaveric, and bench models):
>15,000hrs of procedural experience
(study implants, iterative/benchtop feedback, usability studies)
Interventional (coronary, neuro, peripheral)
Cardiovascular
Ablative therapies
Vascular access
Neuromodulation
Hemostasis
Wound healing
Hernia repair
Dorsal root ganglion (DRG) harvests
Commercialization:
Developing and executing informational, training, and publication-driven lab studies/sessions for:
• Engineers
• End Users
• Principal Investigators (PIs)
• KOLs
• Sales & Marketing Teams
Overall Support:
Program leadership/management
CRO selection & navigation
Regulatory Interaction:
Guidance document interpretation
Pre-sub strategy and presentation
Submission strategy and construction
Deficiency/response strategy and presentation
SEND dataset management
Data Review:
Interpretation
Gap analysis
Company Details
- Employees
- 4
- Founded
- 2018
- Address
- Twin Cities, Mn, Us
- Industry
- Biotechnology Research
- NAICS
-
Research and Development in Biotechnology (except Nanobiotechnology)
- Website
- http://www.osirisdev.com
- Keywords
- Surgical and Interventional Support, Product Development/R&D Support, Program Leadership/Management, CRO Selection & Navigation, Pre-Sub Strategy and Presentation, Submission Strategy & Construction, Deficiency/Response Strategy & Presentation, SEND Dataset Management, Overall Data Review/Interpretation & Gap Analysis, Animal, Human Cadaveric, & Bench Models, Design & Execution of Sales/KOL/Publication-Driven Studies.
- HQ
- Twin Cities, MN
Osiris Med Dev Questions
Osiris Med Dev's website is http://www.osirisdev.com
Osiris Med Dev's LinkedIn profile is https://www.linkedin.com/company/osiris-med-dev
Osiris Med Dev has
4 employees.
View email and phone details for 4
employees at Osiris Med Dev.
Osiris Med Dev's industry is
Biotechnology Research
Osiris Med Dev's top competitors are
Element Research Group (Erg),
Ibex Preclinical Research,
Good Areas,
Element Research Group,
Vdyne,
Fanavaran Jarahyar Sharif,
American Preclinical Services, Now Part Of Namsa,
Pleioflow,
Endpoint Preclinical,
Stryker.
Osiris Med Dev's categories are Biotechnology Research
Osiris Med Dev's founding year is 2018
