ISO 13485 : 2016 Certification

ISO 13485 (Medical Devices Quality Management System - Requirements for Regulatory Purposes)

ISO 13485: 2016 is an internationally agreed standard that sets out the requirements for a quality management system specific to medical device industry.

It is designed to be used by organizations throughout the life cycle of a medical device, from initial conception to production and post-production, including final decommission and disposal. It also covers aspects such as storage, distribution, installation and servicing, and the provision of associated services.

ISO 13485 helps an organization design a quality management system that establishes and maintains the effectiveness of its processes. It reflects a strong commitment to continual improvement and gives customers confidence in its ability to bring safe and effective products to market.

What is a Medical device?

A medical device is an instrument, apparatus, machine, implant, accessory, in vitro reagent, or other similar article, that is intended for use in the diagnosis, measurement, prevention and treatment of disease or other medical conditions.

There is a huge variety of medical devices, ranging from basic hand tools to complex computer controlled machines. These include simple devices like wound dressings and scalpels; durable devices like wheel chairs and dentist chairs; implantable devices like cardiac pacemakers and monitors, prosthetic limbs and prosthetic joints; life supporting devices like respiratory and lung ventilators; sophisticated, software controlled devices like CT scanners and MRI machines; and in vitro diagnostics reagents and test kits.

Benefits of Lexium’s Proven Methodology for ISO 13485:2016 Consulting

At Lexium our highly qualified and knowledgeable subject matter experts will utilize industry best practices while working with your implementation team. In addition, they shall provide guidance to your management staff through entire process. This generally results in a significant improvement in the effectiveness of your quality management system and it’s ability to meet organization’s objectives.

  • Reduced QMS Development and Implementation Time
  • Quicker Path to ISO 13485:2016 Certification
  • Improved Effectiveness and Efficiency of the QMS Processes
  • Employee Training and Skills Development
  • Fulfilment of all legal and regulatory requirements based on your product’s classification
  • Development of a continual improvement culture within your organization

Get in touch to know more We will help you to FastTrack your ISO 13485:2016 implementation