Fulfilling regulations efficiently –
Some questions we help our clients solve:
- Am I keeping an optimal balance between boosting efficiency and keeping up quality?
- How can I effectively manage device history records in order to perform better in audit situations?
- Are my performance parameters adequate to guarantee compliance under given regulations?
- How can I effectively set up an efficient Quality Risk Management process?
- How should I group my product portfolio in order to streamline QC processes?
- How can I manage regulatory compliance of supplied components?
- We got a Warning Letter, what do we do now?
How we help you to uQualize+ your business
We assist you to shape your production processes to medical device regulation without jeopardizing your bottom line. We support you in tuning your quality operations to optimal levels, and design and implement solutions to optimize your processes. In case of a regulatory emergency, we offer fast and full remediation support. Some areas in which we help our clients are:
- Streamline operations to ensure regulatory compliance while maintaining profit margins
- Optimization of QC processes and organizational structure
- Achieve efficient compliance in supplier management processes
- Introduce a Quality Risk Management process and structures and implement FMEAs
- Implement continuous improvement management processes to ensure progressive state-of-the-art evolution of processes
- Set-up, monitor and coordinate multi-workstream transformation programs to quickly boost quality management to a state-of-the-art level to avoid or remediate regulatory emergencies
What’s up in the medtech market…
The medical device industry benefits from opportunities arising from aging society, new discoveries in material science and technological advances but also faces huge challenges especially from increased regulation. Requirements such as validation of components and manufacturing steps, supplier management and QAAs, device history record management and post-market surveillance as well as the recent UD legislation – just to name a few – have to be considered. At the same time higher development costs and increasing complexity of production processes need to be tackled. High-tech medical technology products thus require “high-soph” operations and quality strategies, which need to be efficiently structured to contain costs.