Team Lead, Quality and Regulatory Affairs
Labquality can help medical device manufacturers continually improve their quality management system (QMS). This includes updating the QMS e.g., when corrective and preventive actions are needed, revised standards are published, or regulatory landscape is changing.
The requirement to maintain, keep up to date and continually improve the QMS comes from EU Regulations (2017/745, 2017/746)
and quality management system standard (ISO 13485).
✔ Identifying the changes that trigger QMS updates ✔ Preparing a systematic Gap Analysis for the existing QMS process(es) in relation to the change
✔ Helping the manufacturer to interpret the Gap Analysis and fill in the identified gaps in their QMS
Examples of QMS Gap Analysis we have been working on:
MDD versus MDR | IVDD versus IVDR | ISO 13485 versus IVDR/MDR | ISO 13485 and ISO 9001 standard version changes
ISO 13485 versus US FDA 21 CFR Title 820 (QSR) | ISO 13485 versus MDSAP | ISO 14971 standard version changes