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Get Your Free
ISO 13485 Consultation

Schedule a free consultation to discuss your medical device quality management goals. Whether you need ISO 13485 certification, FDA regulatory support, or a gap analysis, we will tailor a plan to your specific needs.

Schedule Online

Book a free 30-minute consultation directly on our calendar. Choose the time that works best for you.

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Call Us

Speak directly with a medical device quality consultant. Available Monday through Friday, 8 AM to 5 PM PT.

858-240-4353

Email Us

Send us a message with details about your project. We respond to all inquiries within 24 hours.

support@certify.consulting

Your First Call

What to Expect During Your Consultation

Our free consultation is a focused, 30-minute conversation designed to understand your medical device quality management needs and provide actionable guidance. Here is what we cover:

Quality System Assessment

We discuss your current quality system maturity and identify gaps relative to ISO 13485:2016 requirements.

Regulatory Requirements

We identify your specific regulatory requirements, whether that is FDA 510(k), EU MDR, or other international market access needs.

Device Classification & Pathway

We assess your device classification (Class I, II, III, IVD, or SaMD) and determine the optimal certification pathway.

Timeline & Cost Estimate

We provide a tailored timeline and investment estimate based on your organization size, product complexity, and current readiness.

No Commitment Required

The consultation is completely free with no obligation. Our goal is to provide expert guidance so you can make informed decisions about your certification journey.

200+
Clients Served
100%
Audit Pass Rate
6-12
Month Timeline
24hr
Response Time
RAC

Regulatory Affairs Certified (RAPS)

Your consultation is with a RAC-certified consultant qualified to address both ISO 13485 quality management and FDA regulatory strategy.

Jared Clark, JD, MBA, PMP, CMQ-OE, RAC

Medical Device Quality Consultant with 8+ years of experience and 200+ successful certification projects.

Send a Message

Tell Us About Your Project

Provide details about your medical device and quality management needs. We will respond within 24 hours with next steps.

We respond to all inquiries within 24 hours.

Common Questions

Consultation FAQ

The free consultation is a 30-minute call where we assess your current situation and goals. We discuss your existing quality system (or lack thereof), your device classification and target markets, any regulatory deadlines you are working toward, and what it would take to get you to ISO 13485 certification. By the end of the call, you will have a clear picture of the scope, timeline, and expected investment for your project. There is absolutely no obligation — the goal is to give you expert guidance so you can make an informed decision.
Most projects begin within 1 to 2 weeks of the initial consultation. After our discovery call, we prepare a detailed proposal outlining the scope of work, project timeline, milestones, and investment. Once you approve the proposal, we schedule the formal gap analysis and kickoff meeting. For companies facing urgent regulatory deadlines — such as an upcoming FDA submission or EU MDR transition — we offer accelerated timelines with priority scheduling to meet your deadline.
Yes. While we are based in San Diego, California, we work with medical device companies across the United States and internationally. ISO 13485 is an international standard recognized worldwide, and our consulting covers FDA, EU MDR, and other global regulatory frameworks. Remote consulting is fully supported through video conferencing, shared document platforms, and regular progress reviews. Many of our most successful projects have been conducted entirely remotely.
Our Location

Based in San Diego, CA. Serving medical device companies nationwide.

Remote consulting available for companies anywhere in the world.

Ready for ISO 13485 Certification?

Schedule a free consultation to discuss your medical device quality management goals, assess your current readiness, and get a tailored roadmap to certification.

Schedule Free Consultation 858-240-4353

No commitment required. Expert guidance on your medical device QMS certification journey.