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20 things you need to know about SOP for medical devices
So, you are a medical device creator and you reached to the point when you see that SOP (Standard Operating Procedure) is required by the FDA, ISO, and other regulatory bodies.
But what SOP actually means? By definition, it’s a document that describes the regularly recurring operations relevant to the quality of the investigation. The aim...
20 facts about FDA Approval Process for medical devices
Every company that plans to sell its meddev on US grounds has to register with the FDA. In the list, you will find key points of what awaits you.
4 steps how to carry out RCA
Root cause analysis is basically a process with a systematic approach for identifying a problem
CAPA Checklist - Step by Step Guide
Besides its compulsory requirement, CAPA helps companies to enhance their quality system to reduce risks and avoid potential problems in the future.
ISO 9001 – 2015 Checklist
If you do QMS right, it’s not a burden, not an added layer of management that gets in the way. The following checklist will guide you.
ISO 13485 – 2016 Checklist
This Checklist will allow you to get more done, save time and reach your goals quicker.
QMS for Beginners – A quick guide on where to Start ! …Part 4
Where to Start and what to do when you need to implement a QMS? The following 13 items will guide you. We will help you bootstrap your QMS efforts.
QMS for Beginners – A quick guide on where to Start ! …Part 3
Where to Start and what to do when you need to implement a QMS? The following 13 items will guide you. We will help you bootstrap your QMS efforts.
QMS for Beginners – A quick guide on where to Start ! …Part 2
Where to Start and what to do when you need to implement a QMS? The following 13 items will guide you. We will help you bootstrap your QMS efforts.
QMS for Beginners – A quick guide on where to Start ! …Part 1
The following 13 items will guide you. We will help you bootstrap your QMS efforts.