Certifications
...without complications!
Certifications EN ISO 13485 / EN ISO 9001
Without complications!
System Design
We design a custom, efficient quality system compliant with regulations.
Implementation
We implement the system in your organization with continuous support.
Certification
We manage the certification process before the Notified Body.
Although it is not necessary to be certified under a quality standard to achieve CE marking success, it is essential to have a documented and implemented quality system.
ISO 13485 is a standard based on ISO 9001, its main objective is to meet customer expectations and regulatory authority requirements.
At MeDev Consulting, we handle the design and implementation of a quality system that satisfies the Notified Body while generating value for your company.