Expert Guidance Through IEC 60601 Compliance - Including the 4th Edition Transition
Borderless MedDev's consultants help medical device manufacturers build a clear IEC 60601-1 compliance strategy, prepare for testing, and manage certification and submission — with direct access to the people who help shape the standard.
Vice Chair, IEC SC 62A
Helping shape future IEC 60601 editions
AAMI-Certified Lead Auditor
MDSAP & ISO 13485
Decades of Experience
Helping shape future IEC 60601 editions
Why Borderless MedDev
We Didn't Just Learn the Standard. We Help to Write It.
Our consultants wrote the book, literally. With decades of industry experience, our team has brought countless devices to market and helped shape key standards, including IEC 60601-1. We have navigated the compliance process from every angle, and now we are here to share what we have learned with you.
Market Access Fast-Track
Our efficient, strategic approach keeps your timeline moving without unnecessary delays.
A Team You Can Rely On
We act as your partner, coach, and sounding board, ready to support you at every turn.
Proven Track Record
We have helped hundreds of medical devices through compliance and into market access.
From Compliance Strategy to Certification
Whether you're starting your first IEC 60601-1 project or transitioning to the 4th edition, we build the plan and manage the process alongside you.
Market Access Fast-Track
We assess your device against IEC 60601-1 and applicable particular and collateral standards, then build a clear roadmap to compliance.
Test Plan Development
We define the test plan and documentation your accredited test lab needs, so testing goes smoothly the first time.
4th Edition & Amendment Transition
We assess your device against IEC 60601-1 and applicable particular and collateral standards, then build a clear roadmap to compliance.
Submission & Certification Support
We manage documentation and communication through certification and FDA submission, start to finish.
Borderless MedDev builds your compliance strategy, test plan, and documentation, and manages the certification process on your behalf. Physical testing is performed by accredited third-party test labs, not by Borderless MedDev.
Meet Your Consultants
When you work with Borderless MedDev, you work directly with seasoned experts. There are no hand-offs and no junior staff. We speak the language of regulators so you can move forward with confidence.
Brodie Pedersen
Founder & Chief Regulatory Officer
In the medical device field since 1999, Brodie helps companies bring devices to market through design controls, quality systems, and FDA/FCC regulatory filings.
Vice Chair, IEC SC 62A — developing future versions of the IEC 60601 family of standards
Convener, IEC SC 62A WG 38 (IEC 60601-1-1, 4th edition)
Electrical Engineering graduate, North Dakota State University
Scott Blomberg, MBA
Founder & Chief Scientific Officer
Over three decades in the medical products industry, guiding small, medium, and startup device companies through regulatory planning and global commercialization.
AAMI-certified Lead Auditor, MDSAP & ISO 13485
Inventor on 9 U.S. patents and several international patents
Led dozens of clinical products to successful global launch