Safety and certifications

Safety

The management of surgical implant flows requires cumbersome procedures to guarantee traceability, quality, product integrity given the sensitivity of their nature and destination.

Implanet has for 18 years now been committed to providing implants of uncompromising quality and performance for various segments of orthopedic surgery. In order to achieve the highest level of quality and safety for the future patient, Implanet imposes and respects a triple quality control based on very precise specifications. This takes place at the 3 key stages of product manufacture:

In the factory, a 1st quality control during production
A 2nd control on leaving the factory to check product conformity
A 3rd control in our specialized unit at headquarters
 

Always close to its customers and keen to make life easier for its medical partners, Implanet has set up a system to simplify the control and inventory of its implants. This is designed to save time and reduce the risk of human error:

Individual, sterile packaging: avoids sterilization before use and possible deletion of reference and batch numbers,
A peelable traceability label containing all implant information: to be stuck directly onto the register.
 

This organization enables productivity gains to be shared between all those involved in the care chain, while achieving uncompromising levels of health safety and information.

Certifications

Implanet is a company specifically designed and organized to meet the current requirements of our healthcare systems and, above all, to support them as they evolve and adapt to future challenges: providing better care by optimizing the use of necessary resources, whether human or financial, without ever compromising on product quality.

In this context, all our products are tested and comply with various standards and regulatory requirements:

  • Current ISO and ASTM standards
  • Requirements of European Directive 93/42/EC: CE Marking
  • Requirements of FDA CFR Part: 510 (k) Marking
  • Requirements of ANVISA (Brazil)