Cisteo MEDICAL extends its ISO 13485 certification scope to active implants and software

Active implantable medical device pacemaker

We are pleased to announce the renewal of our NF EN ISO 13485: 2016 certification.

Good news that does not come alone since we have extended our scope of certification, which now includes the design, development and manufacturing services of:

Active implantable medical devices
Electro-medical devices integrating electronics and embedded software

Already existing within Cisteo MEDICAL, these services are at the heart of the solutions that we wish to provide to medtech start-ups .

Our quality management system has undergone significant developments while maintaining consistency and compliance praised by auditors .

A single provider to simplify the development of your medical device (from R&D to mass production)

With this development, Cisteo MEDICAL renews its commitment to medtech start-ups and underlines our desire to be a single point of contact for:

Provide specialized expertise and technical skills in line with regulatory requirements
Provide scalable and sufficient production capacities in line with volume increases

An activity around electro-medical devices which is taking shape

Thanks to a multidisciplinary team, Cisteo MEDICAL now has the capacity to ensure the R&D, design and manufacturing phases of electro-medical devices integrating electronics and embedded software (class A, B and C) .

Software development is carried out in compliance with the IEC 62304 reference standard and we take the regulatory context into account from the first design stages in order to propose a compliant prototype and/or proof of concept :

On the electronic aspect: this is materialized in particular in the choice of components and in compliance with the applicable standards (Standard 60601-1 and collateral standards)
On the software side: we pay particular attention to the writing and documentation of the software life cycle

Three aspects have been put in place in order to carry out these services in the best conditions:

Training in essential requirements
The documentation
Resources

Expertise in medical devices up to class III and active implants

The certificate now includes the concept of active implantable device . Skills already integrated within the company and which are now recognized from a normative point of view.

Following the R&D and design stages, Cisteo MEDICAL monitors the developments of the start-ups for which it works and provides services such as industrialization and subcontracted manufacturing of electro-medical devices .

Thanks to these different developments, we are committed to building a long-term partnership which is structured around the following stages:

Co-design between electronics, mechanics and designer teams
Industrialization
Assembly, mounting, electrical wiring, control and verification

Production capacities that increase and adapt to the evolution of start-ups

This certificate renewal also sees something new: the certification of a new manufacturing site .
Based a few hundred meters from our main site, this location hosts an area specifically designed for the assembly and wiring of electro-medical machines. This site also offers the possibility of dedicating an area for specific manufacturing, a flexibility appreciated in the scale-up stages.

This new site also includes a clean room configured according to ISO7 requirements and thus offers our manufacturing customers additional capacities.