QUALITY MANAGEMENT
QUALITY UNDER CONTROL
A sustainably, certified Quality Management System in accordance with ISO 13485 not only helps you to control and improve your company, but also to secure it's long-term existence and satisfy your customers.
YOUR Challenges
We focus on your demands.
Are you planning to CE-mark your medical device?
Do you need a Quality Management System according to MDR and ISO 13485?
Has your Notified Body detected deficiencies concerning your documentation?
Are you looking for regulatory support with quality-related issues?
Do you need additional human resources?
Are you looking for external know-how and independent expertise?
YOUR BENEFITS
We have been working in the field of Regulatory Affairs and Quality Management since 2004 and can draw on experts with more than 20 years of professional experience. Benefit from our years of experience.
We live quality and the requirements of ISO 13485, as well as the requirements of Regulation (EU) 2017/745.
Our team supports you in different areas of quality management: strategic planning, creation of your quality management manual, development of SOPs, independent implementation of internal audits, training, support during audits
by your
Notified Body.
QUALITY MANAGEMENT AT A GLANCE
Depending on your requirements, our Quality Management activities cover the following aspects.
1
Project Kick-off
All the necessary information is exchanged (including a gap analysis). Afterwards we determine the scope and strategic approach together with you.
2
Quality Management Manual
The Quality Management Manual is the backbone of your QM system, on which we work together with you and define your quality policy and objectives.
3
Creation of ISO 13485 and MDR compliant processes
We help you with the creation and documentation of your processes, according to your needs. Most of the processes also include applicable templates that we can develop for you.
4
Internal audits
Your system lives on improvement. In order to regularly check where there is potential for improvement, you need to carry out internal audits. We are happy to support you in this.
5
Training
Training is the be-all and end-all of any QM system. We make your team fit and contribute our expertise.
6
External audits according to ISO 13485
The Notified Body or the authority is coming? We support you in the preparation phase, during the audit and in the processing of deviations.
Contact our experts!
Do you have any further requests?
SOP-Update
We will show you how to coordinate your processes and SOPs so that they are ideally interlinked without inconsistencies.
Inquiry