- Integra MicroFrance Presentation
- Certification and Traceability
- Quality, Security and environmental policy
MicroFrance® instruments meet the requirements of Directive 93/42/EEC with respect to EC marking. They are Medical devices from class I, IIa, or IIb according to appendix IX of the directive.
Furthermore, we have NF EN ISO 13485:2012, MDSAP and ISO 14001:2015 certificates for the activities of design, manufacturing, inspection, and marketing of active and non-active instruments, including electrosurgical instruments.
These certificates also cover repair activities and thus ensure you that the work will be of the same quality as it would during manufacturing.
ISO certificates and EC certificates available in PDF form:
Update : December 2018 (Integra MicroFrance®)
The quality, safety, and environmental policy of Integra MicroFrance has been consistently adopted and implemented. It fully adheres to and integrates:
- Integra’s values.
- Integra’s quality policy.
- Designing, developing, producing, and providing our clients with instruments that are the most suited to their needs, particularly in terms of environmental requirements.
- Generating a reasonable profit from our activities so as to be able to meet our obligations, maintain our rate of growth, and reach our goals while also making sustainable development a priority.
- Recognizing the worth of employees and creating a satisfying work environment that provides security, the possibility for promotion, and participation in the company’s success.
- Satisfying the legal, regulatory, and normative requirements, those pertaining to the environment and safety, and other applicable requirements to which we’ve subscribed.
- Implementing the means necessary to maintain and continuously improve the efficiency and adaptability of the safety and environmental management system.
- Initiating an environmental protection program that includes a better use of natural resources, better pollution prevention, and more generally improving the sustainability of our impact on the environment.
Pierre DE TAILLANDIER,
The manufacturing site for Integra ® MicroFrance® instruments in Saint Aubin le Monial uses the Datamatrix ECC200 GS1 code for the traceability of certain MicroFrance® references.
The DataMatrix code is a high-density, two-dimensional barcode symbol that enables a large quantity of data to be presented on a small surface. The DataMatrix code is in the public domain, which means that it can be used in any application without having to pay royalties. The “square” DataMatrix is the most commonly used and allows the greatest amount of data to be encoded according to the ISO/IEC 16022 standard :
The GS1 system is characterized by the use of ECC200 coding from DataMatrix, which provides the maximum level of security. The DataMatrix code requires camera reading technology.
What is encoded at MicroFrance®:
- > GTIN: MicroFrance® reference number
- > Lot number
- > Serial number
Using this technology, the serial number :
- > is not marked on the instrument in a “legible” way;
- > allows the instruments to be identified in a unique fashion;
- > can be used by the sterilization centers to differentiate between instruments from the same batch.
Example of a DataMatrix code on a MicroFrance® instrument: