Rovipharm.com will soon no longer exist

 

Rovipharm has joined the SGH Healthcaring group! Why?

 

  • To meet your needs for standard or bespoke manufacturing or medical subcontracting more effectively.
  • To offer you outstanding quality, secure sourcing and faster response times

 

Want to find out more?

 

 

 

Discover the full range of SGH products and services

QUALITY

QUALITY SYSTEM

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:

OPERATORS :

Visual inspections

 

Dimensional  inspections using gauges and mistake-proofing (poka yoke)

QUALITY MONITORS :

Validation of start of production

 

Visual inspections

 

Dimensional inspections / SPC

 

Functional inspections

 

Review and production release

 

 

Pôle d’Activités de Lucinges

86, Route du plan d’eau - TREFFORT

01370 VAL-REVERMONT - France

contact@sgh-healthcaring.com

Tél.  +33 (0)4 74 42 39 39

Fax. +33 (0)4 74 42 39 31

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