We Are Implantable Medical Device Experts.
We ensure we get our clients medical device products to market on time, on budget, and hassle free.
“At ARC we provide medical-device development with expert up-front strategies and implementation that controls costs and gives confidence to meet milestones and drive business development success.”
— Chris Weaber, Founder
At Arthroplasty Regulatory Consulting, we take a conservative, “first-time right” approach to product development, emphasizing patient safety and regulatory compliance. With our expertise, we ensure proper planning by establishing a strong foundation early to minimize rework, reduce uncertainty, and support the successful launch and lifecycle of your products.
Services
Regulatory Strategy
Utilizing “first-pass” strategies that build confidence, minimize uncertainty, and establish predictable development timelines to keep your project moving on schedule.
Product Development
Upfront testing and sterilization planning that safeguards your budget and avoids repeat testing.
FDA Submission
We provide the full FDA preparation and submission, ensuring your pathway to clearance is efficient, compliant, strategically sound, and hassle-free.
Product Validation
Providing proven product development strategies that drive your commercialization success while keeping you on budget.
Who We Work With
ARC partners with innovators at every level of the medical device industry. From individual surgeons looking to bring new ideas to life, to major corporations seeking specialized expertise, to smaller companies expanding their product lines — we support projects of every size and complexity. Whether it’s a single prototype or a full-scale development program, we deliver the experience and precision needed to give you the confidence to move your concepts into reality.
Client Reviews
“I had the pleasure of working with Chris Weaber for eleven years at Total Joint Orthopedics, and we continue to work with him through his consultancy, Arthroplasty Regulatory Consulting.
We affectionately call Chris our FDA Whisperer because he has an exceptional ability to navigate complex regulatory pathways and translate requirements into practical, efficient strategies. He's well respected by colleagues, FDA reviewers, and our larger regulatory consulting partners alike.
What sets Chris apart is his responsiveness and his reasonable, analytical approach to testing requirements. He finds the right path forward that satisfies regulatory requirements while keeping projects moving efficiently.
Since launching Arthroplasty Regulatory Consulting, Chris has continued to provide the same high-quality regulatory guidance we relied on for a over a decade. I highly recommend him to any orthopedic company looking for regulatory expertise they can trust.”
— Erin Hoffman, President and CEO Total Joint Orthopedics“Chris provides great insight into both regulatory and new product validation strategy. Working in the new product space requires an understanding of the product development process, from concept to final production and validation. Chris provides this understanding and offers solid solutions to hurdles that are eventually encountered through the new product introduction process.”
— Roy C. Wiley, BeamAlloy Technologies, LLC“Total Joint Orthopedics has worked with Chris Weaber for almost 15 years and he has been instrumental in obtaining 510(k) clearance for our products. We have been thankful that he has continued to write our 510(k)s and consult on regulatory strategy since he started Arthroplasty Regulatory Consulting. I've personally worked with him for over a decade and would highly recommend his services to anyone looking for regulatory support.”
— Dermott McHugh, Vice President of Product Development, Total Joint Orthopedics
“On several occasions I have engaged with Chris Weaber to consult on various orthopedic innovations that I have developed.
Having a background that combines orthopedic engineering with an in-depth knowledge of matters pertaining to the ever changing rules and regulations, Mr. Weaber thoroughly researches the background of each topic and has been well prepared for all of our meetings. Consequently, he has provided invaluable insight that has guided my decisions. I would highly recommend him to my colleagues for professional guidance.”
— Peter M. Stevens, M.D., Emeritus Professor, Dept. of Orthopedics, University of Utah“I’ve worked with Chris for over a decade, and his considered and pragmatic approach to orthopedic R&D + regulatory strategy has resulted in a proven track record of predictable clearances for robustly developed orthopedic products. I would look forward to working with him again at any opportunity.”
— Eric Dacus, Principal Engineer, Restor3d
Let’s get to work!
It’s easy to get started. Send us a message and an ARC consultant will answer your questions.