The QA/RA Manager is the management representative responsible for the implementation and continued compliance of the Quality Management System (QMS) to ISO 13485:2016. Additionally, the QMS will need to comply with jurisdiction specific requirements such as:
- 21 CFR 820 (FDA QMS Regulations)
- EU MDR 2017/745
- AU TGA Medical Device Regulations
- UK MHRA Regulations
Person Responsible for Regulatory Compliance (PRRC) is a role mandated by EU MDR 2017/745 in Article 15. Their responsibility’s generally overlap with that of QA/RA Manager in a small company however the individual needs to meet minimum levels of competency.
QA/RA Manager and PRRC can be a challenging role to fill for micro or small companies, especially start-ups. Vestech Medical has staff that are experienced QA/RA professionals and can provide the role of QA/RA Manager and/or PRRC for your organisation. It will give you the confidence that your company will comply with QMS as stipulated by the regulations.