ISO 13485 standard
ISO 13485 is an international standard which defines the requirements regarding a quality management system which may be used by an organisation involved in one or several stages of the life cycle of a medical device. Any organisation working in this field may decide to comply with this standard or be contractually bound to do so.
We implement all of the necessary elements, with your teams, for a quality management system that meets with the requirements of this international standard.
Intraco Consulting may thus assist you with pragmatism and common sense to help you obtain the ISO 13485 certification.
Intraco Consulting can assist you with:
- Performing a review of the situation that lists the weaknesses and improvements required for compliance;
- Communicating to the personnel on the project;
- Implementing the management tools and drafting the documents and procedures that will make up the quality system in liaison with your teams;
- Drawing up an action plan for improvement (corrective and preventive actions);
- Performing your internal audits;
- Organising the management review;
- Training your personnel in quality, procedures and customer relations;
- Support during your certification audits;
- Defining areas for improvement.
Testimonies of our clients
Mission "ISO 9001 - Quality & Strategic Consultancy"
The collaboration with Intraco Consulting was very efficient, structured and reliable. They have enabled us to achieve each of our goals.
Mission "Provision of a QA Manager ad interim"
Very professional collaboration with a qualified team attentive to the customer.
Mission "Realization of internal audits ISO 9001 - Quality & VCA - Safety"
The knowledge of Intraco Consulting about our sector and our company helped in building a relationship of trust for several years.
EMAS training mission
Adapted content, great flexibility.
The collaboration with Intraco Consulting met our expectations and allowed us to be better equipped for our next audit.