ROVIPHARM cultivates excellence through a tight integration of the quality assurance tools by all parties involved, regardless whether the product is still a mockup or already in full production. All employees, from development to fabrication, subscribe to this total quality management approach.
To assure this, ROVIPHARM has organized quality control (operators, quality supervisors, technicians) and clear, efficient and proven operational processes.
ROVIPHARM's quality management system is ISO 13485:2016 certified.
ROVIPHARM uses CE marking, applicable to medical devices in compliance with Council Directive
93/42/EEC. ROVIPHARM is a FDA registered facility.
All our manufacturing facilities are in cleanrooms, in compliance with ISO 14644-1. ROVIPHARM adheres to Good Manufacturing Practice (GMP) and quality assurance standards for equipment qualification and validation: DQ, IQ, OQ, PQ.
Quality is an integral part of each new development within the project committee, led by the R&D department.
The Quality Development department analyses the client brief and specifications and applies, depending on the characteristics of the project, the quality tools for qualification and testing (functional analysis, risk analysis, product and process (FMEA), capabilities, control card (SPC), 3D and camera controls, particulate and microbiological tests (bioburden...), which will assure the visual, functional, and dimensional characteristics of the final product.
Quality development is responsible for defining the matching methods and means of control. The approach is based on the Initial Samples approved by the client, product specifications, the manufacturing process and the outcomes of the risk analyses.
Product Quality is based on a clear and precise organization defining everyone's role during the manufacturing process:
Dimensional inspections using gauges and mistake-proofing (poka yoke)
QUALITY MONITORS :
Validation of start of production
Dimensional inspections / SPC
Review and production release
Pôle d’Activités de Lucinges
86, Route du plan d’eau - TREFFORT
01370 VAL-REVERMONT - France