Regulatory roles · Medical devices · EU and Portugal
An outsourced QA Director for your ISO 13485 system
Medical Devices
The outsourced quality assurance (QA) Director rests on a standard, ISO 13485:2016+A11:2021, not on a law. We can take on the role: we run your ISO 13485 quality management system as your outsourced quality lead and act as your interface with INFARMED.
What the role covers
What we do as your QA Director
- An appointment agreement that makes us your outsourced QA Director.
- Monthly compliance reviews.
- Oversight of your quality management system (QMS).
- Management of your notifications to INFARMED in SIDM (Sistema de Informação para Dispositivos Médicos).
- An annual summary.
For which companies. Medical device companies in the EU and in Portugal that run an ISO 13485 quality management system and want its lead from outside the company.
If the system is not built yet. The role runs a system that exists. We can build it first, from your own documents or from a gap analysis, and audit it against ISO 13485 before anyone else looks. See Quality management system.
Questions people ask
Is a QA Director the same as a PRRC?
No. The person responsible for regulatory compliance (PRRC) is the person Article 15 of Regulation (EU) 2017/745 (MDR) and of Regulation (EU) 2017/746 (IVDR) names at a manufacturer. The QA Director rests on ISO 13485, a standard, and runs your quality system. See PRRC and Authorised Representative.
We do not have a full-time quality lead. What then?
That is the case this role is for. As your outsourced QA Director we run the system for you and handle the INFARMED interface, under an appointment agreement.
Who deals with INFARMED?
We do, as your QA Director. We are your interface with INFARMED and manage your notifications in SIDM. Device notification in SIDM is part of this role.
Will you understand our system?
Two people on the team are trained ISO 13485 auditors, and one has more than 15 years in quality assurance and regulatory affairs at a manufacturer of non-active medical devices.
Where this role sits
- Step: Quality management system (it runs alongside the route)
- Related step: Registration and distribution (notifications in SIDM)
- Related roles: PRRC and Authorised Representative · all Regulatory roles
- Beside the role: Ongoing support for monthly regulatory support
What happens next
Our team replies to every enquiry and asks for your devices, where your quality system stands and the date you are working to.