Quality has always been the key element that sets Gruppo Bioimpianti apart and the certifications it holds, which it regularly reviews, are a guarantee of this.

The entire production cycle, the products marketed and the company’s QMS comply with the international standards UNI EN ISO 9001: 2015 and UNI CEI EN ISO 13485: 2016 as well as the regulatory requirements applicable at the European level (EU Regulation 2017/745 and Directive 93/42/EEC and subsequent amendments and additions).

The certifications obtained involve the Notified Body Italcert.

Hip CE Certified

Certificate 270-01-03-DM

Hip CE certified design

Certificate 271-01-02-DM

Knee CE certified

Certificate 272-01-02-DM

Knee CE certified design

Certificate 273-01-03-DM

Shoulder CE certified

Certificate 274-01-00-DM

Shoulder CE certified design

Certificate 274-01-00-DM

CE certified for orthopaedics and traumatology

Certificate 276-01-01-DM

ISO 9001-2015

Quality Management System

ISO 13485-2016

Quality Management System

Our policy

The policy on which the company has been based since its inception is one of continuous improvement so that it can always provide its customers with the best product and the best solution possible for the patient.

In order to achieve the company’s objective of COMPLETE CUSTOMER SATISFACTION, Gruppo Bioimpianti strikes for quality in the following areas:


A key element to be able to offer reliable, effective and innovative devices, taking into account customers’ needs, both in terms of implantable devices and instrumentation.


For the part of the production process that Gruppo Bioimpianti outsources, we only use qualified suppliers who share a strong focus on quality and hold the certifications that prove it.


All levels of of the company are invested in the concept of Quality. Every employee is responsible for the quality of their work, which inevitably determines the quality of the service and product received by the customer. They are aware of their importance and feel like an active participant in the process of achieving the objective. Great importance is attached to training sessions.


Maximum attention is paid to the customer in order to be able to offer a quality service, which is achieved through different activities such as training, support in the operating theatre and comprehensive customer service.


Careful and continuous planning enables the company policy of continuous improvement to be pursued over time and the goal of complete customer satisfaction to be achieved.