Posted on by Bing Wildlife Foundation Public Health Policy Quote

Do Inmates Need Educational Protocols?

ISO 13485
ISO 13485 Medical devices — Quality management systems — Requirements for regulatory purposes is an International Organization for Standardization standard published for the first time in 1996; it represents the requirements for a comprehensive quality management system for the design and manufacture of medical devices.

This standard supersedes earlier documents such as EN 46001 and EN 46002, the previously published ISO 13485, and ISO 13488.

The essentials of validation planning, protocol writing, and change management will be explained.

via ESSENTIALS OF VALIDATION – Do You Really Need It? — Compliance4all

Advertisement

Leave a Reply

Fill in your details below or click an icon to log in:

Gravatar
WordPress.com Logo

You are commenting using your WordPress.com account. ( Log Out /  Change )

Facebook photo

You are commenting using your Facebook account. ( Log Out /  Change )

Cancel

Connecting to %s