Infrastructure requirements according to ISO 13485:2016
Waqas Imam
Updated: October 9, 2023. The manufacturing, design, or supply of any product or service needs an infrastructure – without infrastructure,...
Updated: October 9, 2023. The manufacturing, design, or supply of any product or service needs an infrastructure – without infrastructure, no firm can carry out its activities. Infrastructure includes buildings, workspaces, utilities, process equipment, instruments,...
How to meet ISO 13485:2016 requirements for medical device files
The requirements for medical device files in ISO 13485:2016 are an endeavor by the ISO Technical Committee (TC 210) to...
The requirements for medical device files in ISO 13485:2016 are an endeavor by the ISO Technical Committee (TC 210) to create consistent operations for medical device manufacturers, and also to make their Quality Management Systems...
How to manage the medical device sterilization process according to ISO 13485:2016
Sterilizing medical devices is of vital significance in the medical sector. Even so, at various places in the world, surgical...
Sterilizing medical devices is of vital significance in the medical sector. Even so, at various places in the world, surgical devices are not properly sterilized. As a result, many patients die, while many more are...
ISO 13485:2016 nonconforming product – How to approach the post-delivery actions
Medical instruments are critical healthcare and life-saving devices that are meant for surgeries, implantation, and other medical objectives. Many medical...
Medical instruments are critical healthcare and life-saving devices that are meant for surgeries, implantation, and other medical objectives. Many medical instruments are reused after they have gone through the sterilization process. Any non-conformity in a...
How to comply with ISO 13485:2016 requirements for handling complaints
Medical devices, implants, and surgical instruments are critical healthcare products in which consumers and practitioners look for high precision and...
Medical devices, implants, and surgical instruments are critical healthcare products in which consumers and practitioners look for high precision and accuracy. Therefore, during the production, sales, and other customer-related processes, complaints are a vital and...
ISO 13485 implementation
Updated: September 25, 2023. Now that your company is thinking about implementing a Quality Management System (QMS) and getting certified...
Updated: September 25, 2023. Now that your company is thinking about implementing a Quality Management System (QMS) and getting certified against ISO 13485, you may be wondering about where — and how — to get...
