medical devices industry handbook

medical devices industry handbook

Introduction to the new Medical Devices Industry Handbook.
Medical devices industry range from simple bandages and tongue depressors to the most sophisticated radiotherapy equipment, implants and software for disease screening. These medical devices play an important role in the welfare of the public, whose safety depends on the quality and consistency of those medical products. The medical device industry is one of the most highly regulated sectors in the world. The need for an increasing controlled manufacturing process and environment is critical to ensuring that all manufactured products are fit and meet the specifications for quality to deliver their intended purpose.

Medical Device Regulations set the highest expectations to ensure safety

However, implementing a quality management system that maintains the effectiveness of its processes and meeting applicable regulatory requirements can be challenging for the sector. Organizations may be treading on the finest of lines between distributing safe and effective medical devices quickly to the market, gaining the trust of customers and meeting regulatory requirements.

New Medical Devices Industry Handbook

The handbook ISO 13485:2016 – Medical devices – A practical guide seeks to address all these expectations. Written by a group of technical experts from ISO’s technical committee ISO/TC 210, Quality management and corresponding general aspects for medical devices, the handbook provides users with practical guidance and accurate interpretation of the requirements specified in the ISO 13485:2016Medical devices –Quality management systems – Requirements for regulatory purposes.

Mapped to the structure of ISO 13485:2016, the new medical devices industry handbook offers step-by-step guidance for all organizations in the medical devices sector wishing to implement and maintain a quality management system. It covers guidance applicable to various stages of a medical product’s life cycle, including the gathering of customer requirements, design, development, production, supply chain, installation, servicing and post-market surveillance of medical devices. Aimed at all organizations, regardless of size and the nature of their business, it helps create a level playing field and facilitate the market access of their products globally. The handbook can be used as the go-to reference when questions arise about specific requirements, their interpretation, and implementation strategies.

The medical devices industry handbook also serves as a practical guide for auditors, regulatory agencies and certification bodies, providing in-depth perspective on how requirements can be fulfilled to meet national regulations. It thus allows for a better understanding of the standard when preparing or conducting external and internal audits, as well as establishing local regulations and guidelines.

Alongside its thorough description of ISO 13485, the new medical devices industry handbook also incorporates information from other sources of best practice most commonly used in the medical devices industry to meet the requirements of ISO 13485:2016.

ISO 13485:2016 – Medical devices – A practical guide is available for purchase from your national ISO member or through the ISO Store.

By Sandrine Tranchard on