QA/RA Manager

QA/RA Manager

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.

An Australian Biotech start-up required an experienced QA professional to develop their QMS but also provide mentoring and training in developing a product as per ISO 13485:2016. Vestech Medical provided a QA/RA Manager on a part-time basis. The experience of Vestech’s QA professional enabled the client to focus on product development, whilst Vestech provided QA/RA services leading to successful implementation of an QMS as well as product launch in Australia.

For more information on how else Vestech Medical can support you,

see the links below.