James Bradbury
Operations and Compliance Director
I joined Advena in August 2021 as QMS Consultant, after working for a number of medical device
manufacturers in my 20 year career. These ranged from manufacturers of Class III implantable
orthopedic devices such as hip implants, and class IIa devices such as autologous blood transfusion
devices, through to self-certified Class I orthotic devices and artificial limbs. My previous roles
include Product Quality Engineer, Supplier Quality Manager, through to heading up the QARA
functions as Head of Quality and Regulatory.
During my career, I also completed 4 years working for a Notified Body, where I progressed from
Lead Auditor under MDD and ISO 13485, to Global NB Operations Manager.
In January 2023, my role changed, and I now responsible for the compliance of Advena’s own QMS, as well as managing our external training programme.
This service will see a range of standard and bespoke training sessions being made available, not just for our existing clients.
While this is in the development phase, we will be expanding our services in this area beginning later 2023. Watch this space!!
