Quality13485, LLC is a medical device quality management consulting and audit service provider based in Madera Ranchos, California, USA. Its core goal is to help organizations build and maintain quality management systems that comply with ISO 13485 and FDA Title 21 CFR 820/QMSR requirements. Based on the website content, it is not a SaaS or enterprise software product in the usual sense, but a professional service focused on human-led consulting, auditing, and compliance guidance.
Its services cover QMS development, implementation, and maintenance; ISO 13485 compliance consulting; FDA regulatory interpretation; QMS audits and gap analysis; internal audits; and audit-readiness support. The site also mentions ISO 14971 risk management for service activities, as well as PHI risk identification and mitigation in medical device servicing processes. Its target customers are highly specific: independent service organizations, medical device installation/removal providers, MRI/CT/X-ray/mammography imaging equipment service providers, refurbishment and remanufacturing companies, and third-party service organizations supporting OEMs.
The website does not disclose any packages, pricing, project timelines, or service levels. It only provides contact channels including phone, email, WhatsApp, a contact form, and an Online Bill Pay portal. As a result, buyers need to discuss requirements, scope, and fees directly before procurement. No free plan or trial is mentioned, though the site does offer several downloadable PDF resources, such as QMS introductory materials, a code of ethics, and a certification body question checklist.
Its main advantage is its highly vertical positioning, centered on ISO 13485 and FDA compliance scenarios for the medical device service industry, with coverage across the full path from system development to audit preparation. It may be valuable for service organizations that have not yet established a structured QMS or are preparing for certification or customer audits. The limitation is that it lacks the capabilities commonly seen in SaaS products: there is no clear mention of a cloud platform, self-hosting, account permissions, team collaboration, third-party integrations, APIs, automated workflows, or reporting systems. It also does not provide case studies or transparent pricing.
It is best suited for medical device service, installation, refurbishment, and imaging equipment service companies operating in the United States or under the U.S. regulatory environment, especially teams that need to align ISO 13485:2016 with FDA QMSR. Its accessibility from China cannot be determined from the available text. For Chinese companies, cross-border communication, time zones, payment methods, and regulatory adaptation differences should also be considered. If the primary market is China, it may be worth first comparing local ISO 13485 consulting firms or medical device QMS software vendors.
β This review is compiled from public sources and does not constitute a purchase recommendation. Verify all facts on the vendor's official site. Verify on quality13485.com official site.
quality13485.com is an Unknown SaaS Tools provider. TG4G tracks its product information, an overall rating of 5.0/10, and a China-accessibility score of Limited (proxy recommended). Click "Visit Official Site" to reach quality13485.com directly.