Our Team
When you work with Borderless MedDev, you work directly with seasoned experts. There are no handoffs and no junior staff. We speak the language of regulators so you can move forward with confidence. You do not have to figure it out alone. We will guide you across the finish line.
Brodie Pedersen
Founder and Chief Regulatory Officer
Brodie Pedersen has worked in the medical device field since 1999. He assists companies in placing their devices in the marketplace through application of design controls, quality system implementation and regulatory filings with the FDA and FCC.
Brodie has grown his experience throughout his career as an expert in standards development and currently serves as the Vice Chair of IEC SC 62A working to develop future versions of IEC 60601 family of Medical Electrical general standards. Brodie is the Convener of IEC SC 62A WG 38 for Environmental ME standard fragment IEC 60601-1-1 4th edition, and a participant in the working group IEC SC 62A WG 37 for General ME IEC 60601-1-1 4th edition.
He is an Electrical Engineering graduate of NDSU (North Dakota State University). His career includes work in the EMC facility of TÜV Product Service, Nonin Medical Inc. and Logic PD. Through these roles he has established skills in Quality Assurance and Regulatory Affairs. Assuring the regulatory compliance, safety and performance of medical patient monitoring technology. This includes the aspects of software, cyber security, wireless certification, electrical safety, labelling, human factors usability and quality system management. The regulatory roles include 510(k) submissions, health Canada device licensing, CE marking among other jurisdictions.
Scott Blomberg, MBA
Founder and Chief Scientific Officer
Scott Blomberg, MBA, brings over three decades of experience in the medical products industry, specializing in areas such as regulatory compliance, quality systems, and global product commercialization. As an AAMI-certified lead auditor for quality systems under both MDSAP and ISO 13485, he has demonstrated a deep understanding of international standards and practices.
In his role as a consultant, Mr. Blomberg is a passionate advocate for small, medium, and startup medical device companies, guiding them through strategic regulatory planning and global commercialization. He works closely with the US FDA on behalf of his clients to secure product clearances and navigate regulatory actions effectively. His expertise in quality systems has enabled numerous companies to achieve full certifications for ISO 13485 and MDSAP, ensuring compliance and operational excellence.
Throughout his career, Mr. Blomberg has held diverse technical and leadership roles, driving the development and global commercialization of numerous medical technologies. His contributions have culminated in the successful launch of dozens of clinical products worldwide. As the inventor behind nine U.S. patents and several international patents, his pioneering spirit and technical acumen have left an indelible mark on the medical device industry.