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Announcing the Launch of Borderless MedDev

Sep 27, 2021

Company Provides Access to Regulatory and Quality Systems Experts for the Medical Products Industry

Combining the expertise of industry veterans Brodie Pedersen and Scott Blomberg, Borderless MedDev has assembled a team of experts to serve our client partners. Mr. Pedersen, Founder and Chief Regulatory Officer has decades of experience in the industry shepherding many innovative technologies through the FDA and currently serves as the vice-chair of IEC SC 62A which is responsible for the 60601 standards. Mr. Blomberg, former CEO of LifeHealth (point of care in vitro diagnostics) also has decades of experience in the industry has led the development and full commercialization of dozens of new products throughout the world. In addition to Pedersen and Blomberg, the team includes Senior Consultant Bill Nagel adding his proven expertise in statistical analysis as well as Quality Assurance and Regulatory Affairs.

“I am excited to have put together such an experienced team. We look forward to seeing our client partners succeed in their medical instrumentation endeavors by applying our skills to help them achieve their regulatory and quality systems goals.” Brodie Pedersen, CRO and founder.

Borderless MedDev is leading efforts in several areas for small and medium sized medical instrumentation manufacturers. These include regulatory strategic planning, regulatory submissions, quality systems planning and implementation. Borderless MedDev supports the entire FDA 510(k) process including remediating submissions that have been presented with roadblocks. The team also is adept at performing independent quality systems audits, supplier qualifications, and formal supplier audits.

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