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
MDSAP
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.

Our Experience

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.

Quality Management System

Regulatory

QA/RA Manager

QA/RA Manager

For more information on how else Vestech Medical can support you, see the links below.

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

see the links below.