QuantièmePlus SA

About QuantièmePlus

QuantièmePlus SA is a Swiss medical technology company based in Gland in the Canton of Vaud, between Geneva and Lausanne. Founded in 2015, the company develops and distributes sterile and reusable single-use instruments, known as Ancillaries, for orthopedic surgery, including drilling and milling instruments. Services include product development (R&D) as well as operating an eIFU system for electronic instructions for use, allowing customers to retrieve the valid manual by product number. The company is certified according to ISO 13485 and applies ISO 14971 for risk management. QuantièmePlus is also registered with the US FDA and supplies customers in Europe, the USA, and worldwide.

Site

Gland

Processes

Development and distribution of sterile and reusable single-use instruments (Ancillaries) for, eIFU System (electronic instructions for use)

Certificates

ISO 13485, ISO 14971

Founded

2015

Employees

2–10

Industries

Medical Technology, Orthopedic Surgery, Biotechnology

1. 01

   Product Development (R&D)

2. 02

   Manufacturing as Legal Manufacturer

3. 03

   Quality Management (ISO 13485)

4. 04

   eIFU System / Documentation

5. 05

   Worldwide Distribution

Locations

Quality and Standards

QuantièmePlus operates with a quality management system according to ISO 13485 and applies ISO 14971 for medical device risk management. The company is registered as a manufacturer with the US FDA (Registration 3019916034).

History

1. 2015

   Company founding