Monthly quality and regulatory support means running a medical device manufacturer’s quality and regulatory work through an ongoing partnership. In this model EUmediq does more than give directions: it shares the responsibility, finds solutions and works alongside your team when it comes to implementation.
Who is it for?
Not every company has a dedicated team of specialists to keep track of the ISO 13485 quality management system and the requirements of the MDR (EU Medical Device Regulation 2017/745) at all times. That should not be a reason for quality and regulatory processes to fall behind.
Processes that need continuity
These processes cannot be set up once and left alone; they need work every month:
- Keeping documents up to date
- Managing nonconformities and corrective and preventive actions (CAPA)
- Risk management
- Keeping the technical documentation sustainable
- PMS (post-market surveillance) activities
- Monitoring regulatory changes
- Audit preparation
The monthly support model
With a monthly consultancy and operational support model tailored to your company’s needs, EUmediq takes an active role in managing these processes. The aim is to integrate the expertise you need into your existing organisation and to give your quality and regulatory processes a planned, effective and sustainable structure.
Keep your quality and regulatory processes going through a continuous, implementation-focused partnership.
EUmediq | Planning together, implementing together, reaching sustainable success together.
