Quality & Regulatory
Quality and regulatory confidence, quantified.
ATL Medical's quality and regulatory confidence are demonstrated through quantifiable, long-term success—90+ technical files generated and supported, ISO 13485 certification, and FDA, EU MDR, and other international notified-body registrations. This isn't a checkpoint bolted on at the end of a program; it's built into the engineering process from Design & Development onward.
90+
Technical files supported
ISO 13485
Global certification
15-20
Audits hosted per year
What ATL Medical's quality system covers.
ISO 13485:2016
Costa Rica, Dongguan, Maple Grove, Cardiff, and Springville — 5 of ATL's 6 sites, from accredited certification bodies.
ISO 14001:2015
Certified in Dongguan. Cardiff (UK) is targeting certification by the end of 2026.
FDA Establishment Registration
Costa Rica, Dongguan, Maple Grove, Cardiff, and Springville registered as medical device manufacturers.
Cleanroom & controlled environments
Class 8 cleanrooms in Costa Rica, Dongguan, Cardiff, and Springville. Controlled rooms also at Maple Grove.
Regulatory pathway support
Predominantly 510(k) and MDD CE Mark, transitioning to EU MDR. ATL helps customers compile their own CE Mark technical files.
Customer & regulatory audits
15–20 customer and regulatory audits hosted per year across all sites.
Regulatory alignment isn't optional. It's essential.
ATL Medical maintains the certifications and quality systems required to support global medical device development and manufacturing. Our manufacturing facilities are FDA-registered and ISO 13485-certified, with Class 8 cleanrooms and controlled environments across our sites. We adhere to Current Good Manufacturing Practices (cGMP) and maintain ITAR compliance where applicable.
These standards keep our processes, documentation, and quality systems audit-ready and aligned with the regulatory expectations of leading medical device OEMs. Review our certificates below.
The details behind the credentials.
What's the breakdown of the 90+ technical files by pathway?
Predominantly a combined 510(k) and MDD CE Mark submission — with a growing number transitioning to the EU MDR CE Mark in recent years. One product went through full clinical trials before CE marking.
Which sites hold ISO 13485 and ISO 14001 certification?
ISO 13485: Costa Rica, Dongguan, Maple Grove, Cardiff, and Springville — five of ATL's six sites, all from accredited certification bodies. ISO 14001: confirmed at Dongguan; Cardiff is targeting certification by end of 2026.
Is the Design History File built in from day one?
Practice varies by site. For products from the Cardiff (UK) site, the customer owns the DHF, but the Cardiff team develops it from the customer's project proposal or user requirements — meaning ATL still shapes the DHF's structure and content even when the customer retains formal ownership.
Does ATL support customers after a device ships?
Yes — all ATL sites support post-launch complaint investigations for customers.
What do OEM engineers and quality managers consistently respond well to?
ATL's harmonized, regulated approach to development and manufacturing — with the flexibility to develop and manufacture at the same site, or develop at one site and manufacture at another, without losing quality continuity.
Due diligence and sourcing minerals responsibly.
ATL Medical is committed to ethically sourcing minerals to prevent human rights abuses and reduce product risk. We select and use partners that do not use forced or child labor or source minerals from high-risk regions. We monitor our supply chain by following the Responsible Minerals Initiative (RMI) and completing the industry Conflict Minerals Reporting Template (CMRT) process.
We have also partnered with third-party agents to expand our ability to research our supply chain, report efficiently, and comply with applicable laws and industry regulations.
One quality thread, wherever the work happens.
Whether a program develops and manufactures at the same site or moves from development to a different manufacturing site, ATL Medical's quality system holds together without losing continuity—something OEM engineers and quality managers consistently respond well to.
Have regulatory questions about your program?
Talk to an ATL Medical engineer about your program.