Re: What is horizontal and vertical standards in EU technical File - ER checklist?
Ethan
A quick google search gave this from the Molnycke web site
"For the purposes of EU medical device regulation, standards are essentially divided into "horizontal" and "vertical" standards. Horizontal standards are those that apply equally to all medical devices.
Examples are EN46001 and EN46002 for quality management in manufacturing, EN30993 for biocompatibility, EN552 for sterilisation, and EN980 for symbols. Vertical standards apply to specific products or product groups. Examples are EN600 for condoms and EN455 for medical gloves"
Cheers and a happy Christmas
Rob