Certifications
...without complications!
EN ISO 13485 / EN ISO 9001 Certifications
No complications!
System Design
We design a custom quality system, efficient and compliant with regulations.
Implementation
We implement the system in your organization with continuous support.
Certification
We manage the certification process with the Notified Body.
Although certification under a quality standard is not strictly necessary to achieve success in CE marking, it is essential to have a documented and implemented quality system.
ISO 13485 is a standard based on the ISO 9001 standard; its main objective is to meet customer expectations and the requirements of regulatory authorities.
From MeDev Consulting, we take care of the design and implementation of a quality system that satisfies the Notified Body and at the same time generates value in your company.