Blomberg MedDev
Point of Care Diagnostics Pioneer
I began my career as a scientist at Diametrics Medical (currently LifeHealth) building single use blood gas sensors and assembling them into cartridges by hand. During my tenure there, we scaled up production to millions of units per year and expanded distribution to over 50 countries. Eventually as the President of LifeHealth, I led the acquisition of this entire business. In 2018, Coorstek, a key supplier partner produced this video to highlight our partnership and showcase our automated production capabilities.
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I am eager to help point of care diagnostics developers and manufacturers to see their programs succeed. I can offer the following services:
- Overall business strategy
- Design review leadership
- Regulatory plan development
- Supply chain and manufacturing planning
- Clinical study planning and execution
- US and international distribution planning and expansion
Medical Products Consulting & Contracting Services
I work with established medical products companies and companies that are new to the space to implement and optimize their quality management systems (QMS) to best fit their business. My level-headed approach involves honest, open interactions with the FDA and ISO registrars in any circumstance.
New Quality Systems Implementations and Regulatory Registrations
FDA 510(k) preparation and submissions
ISO 13485:2016 and FDA (21 CFR 820) Quality System Development (companies new to medical product space)
Implementation of Design Controls for technical teams
Training to various elements of FDA Design Controls and ISO 13485:2016 for technical teams and executives
International registrations/certifications of medical products including CE Mark
Quality Systems Optimization
Conversion of QMS to cloud-based solution
ISO Audit and FDA inspection planning and execution
Optimization of QMS to better align with business processes
Alignment of IEC 62304 to ISO 13485 Design Controls
Risk Analysis including updating of procedures to 14971:2019
Mitigations and Troubleshooting
Root cause analysis
Recall/complaint investigation and management
Audit/inspection response management
FDA response advisory
About Scott Blomberg
I have been a professional in the medical products arena my entire career. As a business leader, I approach implementation and optimization of quality systems as a tool to run better companies. I have direct "in the trenches" experience with quality systems and FDA/international regulatory affairs.
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Sparton/Spartronics Design Services- Director of Design Services and Quality Manager
LifeHealth/EasyDx- President, CEO and Board Member
Nonin Medical- Principal Project Engineer, Director of Product Development, and Strategic Alliances Manager
Diametrics Medical (now LifeHealth/EasyDx)- Scientist, engineer, and project manager
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Bachelors of Arts, Gustavus Adolphus College with Physics Major
Masters in Business Administration (MBA), St. Thomas University
Certified to ISO 13485:2016
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Valued Partner
Provides an Extensive list of Business Development Services in the MEDTECH Market
