Quality management for medical device developers means following ISO 13485 standards

ISO 13485

Medical devices can play a key role in life and death situations, so it is vital that this type of product meets a high standard of quality. ISO 13485 includes guidelines that can be used to create an effective quality management system, and it also makes it easier for organisations to meet customer expectations and regulatory requirements. The end result of applying these standards is medical devices that are safe and effective.

What is ISO 13485?

The International Organisation for Standardisation is committed to promoting best practices in industry so as to ensure a high level of quality for consumers. The standards created by this organization can be identified by the letters ISO followed by a number – ISO is an abbreviated form of the Greek word ‘isos’, which means ‘equal’. Manufacturers are usually keen to promote their ISO credentials because it can offer reassurance to consumers and it can lead to improvements in regards to quality and efficiency. If a manufacturer is looking to meet something like European regulatory requirements, part of the process will often involve implementing the ISO standard. It should be noted, however, that the International Organisation for Standardisation does not actually certify organisations, as this is done by accredited certification bodies.

The ISO 13485 is a quality management system that has been specifically designed for the medical device industry – it is a newer standard than EN 46001 and EN 46002 and it supersedes both of these. It includes information on how to establish a quality system, create a quality policy, control quality management, conduct reviews, and promote quality. It also includes information on legal requirements and risk management. While ISO 13485 is a fully fledged regulatory standard, it does not promote improvement within an organisation, as its objective is to simply recognise that the quality system is in place. For this reason, ISO 13485 is usually harmonised with ISO 9001, which expects continuous work towards improving standards within the industry and thus the harmonised standard is considered mandatory.

Gantus Professional Medical Device Development Courses

Gantus provides a number of professional courses specifically designed for people working in medical device development. The design control course provides an introduction into the most common standard used in this industry – it also includes things like design review, planning, and design validation. The project management course also has information about standards that are commonly used in the medical device development process.