ISO for Medical Devices
LNE G-MED, Notified Body for Medical Devices
Iso 9001, Iso 14001, Iso Standards
The International Organization for Standardization (ISO) develops standards that help companies monitor and improve their processes and products, in terms of Quality, Environment, Impact, Safety, Reliability, Efficiency and Interchangeability.
Recognized worldwide by Regulatory Affairs Professionals and Quality Managers, ISO bridges the national standards institutes of 159 countries.
A company that demonstrates adherence to specific standards can earn credibility with its customers, investors, employees and other stakeholders. In addition, many countries mandate certain ISO certifications prior to granting a manufacturer approval to sell products.
Demonstrate Adherence to World Standards through Independent Certification
Regulators rely on the work of accredited third parties to audit companies to ISO standards.
LNE/G-MED is authorized to certify a variety of ISO standards, including:
ISO 9001 Quality Management Systems
ISO 13485 - NF EN ISO 13485 Medical Devices, Quality management systems, Requirements for Regulatory Purposes
ISO 13485 in combination with sterilization standards - Quality certification of sterilization processes
ISO 14001 Environmental management systems, Requirements with guidance for use
OHSAS 18001 – Occupational Health and Safety Management Systems
ISO 27001 - Information security management
ISO 15378 Primary packaging materials for medicinal products, Particular requirements for the application of ISO 9001:2000, with reference to Good Manufacturing Practice (GMP)
, Iso 14001
, Iso 9001
, Iso Standards
, Iso Training