Quality Systems Implementation & Maintenance for Medical Device Companies

Quality Systems Auditing for Medical Device Companies

Make sure your product complies with all FDA regulations and ISO standards. Crakn is a consulting firm that focuses on quality and compliance issues for the medical device industry. We specialize in quality systems auditing with the goal of improving process systems to maximize efficiencies. Our goal is to assist you in the ISO 13485 certification process. With more than 30 years of experience in the field, we have provided hundreds of successful audits to medical device companies, many of which led directly to ISO certification. Contact us today to schedule your free consultation.


Quality &
Regulatory Services

Happy Doctor


Medical Device Sterilizer

Quality System Training
& Implementation

Contact us for a free consultation
Call (925) 526-7950

About Crakn

At Crakn, we take quality seriously and the client is our first priority. Based in San Pablo, California, we have provided quality and regulatory services to companies across the US, Mexico, Canada and Asia. Our team has worked with some of the largest quality systems medical device companies, as well as numerous medical device startups, to manage risk, review processes, and ensure compliance. We work with the FDA, FDB, and notified bodies to deliver everything from high-level support and training to comprehensive audits of your processes, policies, and procedures.

We are proud to offer transparent, market-based rates, and our packages include the travel costs to any destination, including international. Our mission is to provide our clients with quality services that are tailored to their needs and to support them in complying with FDA and ISO regulations.

FDA Quality and Compliance (Medical Devices) »

California FDB Certificates and Licenses »


Thank you for your interest. We look forward to hearing from you soon.

(925) 526-7950

Hours of Operation
Monday - Saturday: 7:00 a.m. - 5:00 p.m.
Emergency Service Available 24/7

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