QMS consulting tailored to medical device and IVD manufacturers
A quality management system per EN ISO 13485:2016 is mandatory for medical-device and IVD manufacturers placing products on the European market — and the first artifact your notified body will examine. We implement, audit and maintain the system end-to-end: CAPA processes, internal and supplier audits, management review and notified-body audit preparation. As a TÜV Rheinland-certified consultancy to the same standard (Cert. SX 1546485-1), we work your file from inside the framework, not from a textbook.
Our QMS services include
From standards implementation to ongoing compliance — covered end-to-end.
QMS implementation
Implementation of QMS according to EN ISO 13485 and EN ISO 9001 — tailored to your product portfolio and scale.
CAPA process
Implementation of corrective and preventive action (CAPA) process to manage non-conformities and continuous improvement.
Compliance audits
Internal, supplier, product and process audits to verify compliance and surface improvement opportunities.
Your QMS file does not exist in isolation. We connect it to your MDR / IVDR submission strategy, technical documentation and post-market surveillance — so an audit finding on one side does not keep reopening problems on the other.
Your questions about ISO 13485 & QMS
EN ISO 13485, the MDSAP scheme, MDR / IVDR-aligned QMS requirements, and applicable regional standards. We tailor the system to your device classes and target markets — not a one-size template.
Yes. MT Promedt is TÜV Rheinland-certified to EN ISO 13485:2016 (incl. AC:2018 and A11:2021) — certificate No. SX 1546485-1, currently valid through January 2028.
Yes. We run MDSAP gap assessments, internal audits, and pre-audit readiness reviews for the participating regulatory regions (FDA, Health Canada, ANVISA, MFDS, PMDA).
It depends on company size and starting maturity. A typical MDR-ready EN ISO 13485 build-up runs roughly 6–12 months from kickoff to certification audit. We give a realistic plan after the first scope review.
Yes — internal audits, supplier audits, and management review preparation. We can also act as your external internal auditor on a recurring schedule.
Yes. We support root-cause analysis, CAPA planning, effectiveness checks, and notified body response drafting until the file is closed.
Download our Quality Management brochure
Service brochure
Quality Management Systems — English
Quality Management Systems — German
Ready to implement or audit your QMS?
Get a tailored EN ISO 13485 / EN ISO 9001 implementation plan and a quote within 24 hours.