ISO 13485
At Apotech, we specialise in guiding companies through the development and maintenance of ISO 13485 compliant quality management systems (QMS). Our experienced team employs a systematic approach, assisting in the establishment of robust processes aligned with ISO 13485 requirements.
We tailor our services to your specific needs, ensuring that every aspect of your QMS meets international standards. Beyond initial implementation, we offer ongoing support through audits, training and strategic insights.
Trusted by top-tier teams worldwide
Our ISO 13485 services include:
- Gap analysis
- QMS remediation
- QMS implementation
- Corrective and Preventive Actions (CAPA)
- Root cause analysis
- Internal audits
- QMS maintenance
We also provide guidance on third-party certification and testing providers aligned to your device category and can help you prepare efficiently for certification audits.
FAQs on quality systems and compliance
We recognise that the world of quality systems and compliance can be fairly confusing at times. That’s why we aim to make the process as easy to understand as possible by being completely transparent about our services.
Here are some of the questions we are asked most often.
ISO 13485 was introduced in 1996, which happens to be the last time a major update to 21 CFR Part 820 (QSR) occurred. Since that time, ISO 13485 has been modified a few times, and the most recent version – ISO 13485 – is very similar to FDA QSR.
The FDA says it is now time to harmonise the two by replacing the QSR with the QMSR. The primary change here is that Subpart A of the new proposed QMSR refers to ISO 13485 as the basis for compliance with the QMSR but with some minor modifications as discussed below.
This means that all companies required to comply with the QMSR will essentially be following ISO 13485 even if not certified by a third party. Where differences exist between ISO 13485, the Food, Drug, and Cosmetic Act (FD&C Act) and QMSR, the QMSR will prevail.