Explore Our Services

Explore our range of services designed to help you move forward with confidence. With every solution backed by proven expertise and transparent guidance, you’re supported at every step with Arthroplasty Regulatory Consulting.

Inquire Now
Recall, Medical Device, ASTM, ISO, Sterilization, Packaging, Validation, Medical Implants, Regulatory Services, Regulatory Consulting, FDA, 510(k), 510K

What We Offer

At ARC, we make your life easier by offering the advantage of working exclusively with a dedicated expert consultant from initial discussion through final delivery. We provide expert product‑development guidance and proven FDA 510(k) strategies designed to safeguard your budget, create regulatory success, and position your product for a confident, competitive market launch.

  • Providing full Medical Device Development technical expert advisory.

    • New implant product testing strategy and advisory (including Biocompatibility),

    • FDA regulatory strategy, Qsub and 510(k) submission, FDA Official correspondant,

    • New UHMWPE implant expert, implant retrieval analysis and reporting, EU MDR technical, manufacturing and validation documentation

    • Product design validation, design for manufacturability and custom manufacturing process validation.

    • Product cleaning, packaging and sterilization validation.

    • FDA establishment registration and GUDID product listing.

    • Patent development

    Providing direction for internal teams, and work with internal project leaders. Services include direct advisory to hands-on implementation..

  • Providing proven product development strategies that drive your commercialization success.

    From small companies and startups getting their new idea for a medical device to the market, to major corporations with new technologies to enhance patient treatments, we provide development expertise for all aspects of the new product introduction process to bring new ideas to market.

    Our strategies are rooted in a “1st time through the FDA” perspective, with this translating to all aspects of product development.

  • Upfront testing and sterilization planning that safeguards your budget and avoids repeat testing.

    Providing expertise for your projects based on a history of hands-on application of regulatory requirements and standards (ISO, ASTM, AAMI, FDA)

    • Design Control Inputs/Outputs Verification and Validation

    • Validation of Risk inputs and mitigations

    • Biocompatibility

    • Product Cleaning and cleaning process

    • Packaging and Shelf Life

    • Steam, EO and Gamma sterilization

  • Utilizing first-pass strategies that build confidence, minimize uncertainty, and establish predictable development budgets and timelines.

    • We provide informed FDA strategies to set realistic management goals for confidence in market launches.

    • We provide guidance for FDA Establishment Registration and product listing.

    • Qsub, 510(k) eStar, FDA correspondence, eCopy, GUDID (web and xml),

  • Submissions include the strategic goal to address FDA questions before they are asked in order to prevent avoidable delays with a “1st pass through the FDA” perspective.

    • We provide the full FDA preparation and submission for Special, Abbreviated and Traditional 510(k)s, ensuring your pathway to clearance is efficient, compliant, and strategically sound.

    • Official FDA correspondent, providing all Additional Information and Interactive communications.

    • Class I exempt product definition and product codes.

Our Process

Access Regulatory Landscape

You can rest assured that our long-standing expertise ensures a comprehensive and accurate evaluation of the full regulatory pathway, which includes; identifying applicable requirements, and clarifying the strategic implications for the product’s intended use and risk profile.

Translate Requirements Into Strategy

Convert complex regulations into practical, efficient, and achievable strategies that align with developmental goals while safeguarding compliance. Developing a clear, expert‑built project roadmap that anticipates project pitfalls to give you piece of mind from the beginning.

Define The Optimal Path Forward

We will determine the most effective route to satisfy regulatory expectations, anticipate challenges, and establish a clear plan for successful product introduction. Our expert planning ensures you get your project started on the right path.

Resolve Implementation Risks and Barriers

We will apply expertise and up‑to‑date regulatory knowledge to address hurdles, provide well‑researched solutions where every meeting is informed, every recommendation is researched, and every step is designed to move you forward with confidence, and maintain momentum through every stage.

Radiation Sterilization, GAMA. Regulatory Services, Implants, Medical Device, Clearance, FDA, Orthopedic device

  • "What sets [ARC] apart is their responsiveness and reasonable, analytical approach to testing requirements."

    Erin Hoffman

  • "[ARC] provides great insight into both regulatory and new product validation strategy."

    Roy Wiley

  • "...[ARC] has provided invaluable insight that has guided my decisions."

    Peter Stevens M.D.

  • "...[ARC] approach to orthopedic R&D + regulatory strategy has resulted in a proven track record of predictable clearances for robustly developed orthopedic products."

    Eric Dacus

Joint Implants, Orthopedic, Medical Device, Regulatory Consulting, Regulatory Advisory, FDA Cleared

Initiate Your Consultation Today!

Get your project started with us. Complete the form and an ARC consultant will contact you.