qmsWrapper Blog

Find out what is the core of the ISO 9001 standard. qmsWrapper explained it all in simple terms, for QMS beginners. Learn more.

qmsWrapper brought the library folder to its full potential. The easy-access place to put what you need to find easily and much more. Find out here.

Find out if and when you need to perform a GAP analysis for implementing your ISO 9001 or ISO 13485. Learn more about GAP analysis activities.

qmsWrapper has prepared an eye-catching infographic of implementing ISO 13485 standard for you. It includes all the benefits and more. Learn more here.

it’s time for improvement through corrective and preventive action – with qmsWrapper ISO 13485 compliance is easy.

Learn about strategy for identifying the data for analysis because the ISO 13485 requires collecting data from all processes and activities.

A nonconformity is any failure to meet a requirement. Learn how to control it according to ISO13485.

Monitoring and measuring activities of products are the necessary controls to ensure the meddev performs as intended – simplified ISO 13485, by qmsWrapper.

How to inspect product quality, determine the quality of your in-house processes, continuously improve methods of measuring customer satisfaction…

Control of monitoring and measuring medical devices are one of the most important parts of the ISO 13485. Learn from qmsWrapper.

This section of ISO 13485 covers the different elements and resources that combine the realization processes to ensure conformance to meddev specifications.

Recognizing the client's needs and their specific requirements, somehow just imposes for qmsWrapper to expand its capacities and dominate ISO 9001:2015 market.

ISO 13485 requires you to document your purchasing procedure to ensure purchased products adhere to the stated purchasing information. What does that mean?

D&D is explained to prevent failure because if your meddev fails to meet regulatory design requirements, it won’t be able to reach the market.

What is important when determining requirements, when it's time to review, and how to communicate with your customers?

Planning is part of success. And it refers to all phases of the life cycle of your meddev. Chapter of product realization of ISO 13485.

Work environment and contamination control are important and critical for effective and compliant medical device business run. qmsWrapper explains it all.

The importance of the connection between qualified employees, the implementation of QMS, and the maintenance of its effectiveness.

How important is management review input and output while you build your meddev, read this explained chapter of ISO 13485 – all about management review.

In every meddev company, there must be an organizational structure. Learn about responsibility, internal communication, and management representative.

You will learn why without planning it’s impossible to build quality into your meddev and company from the start.

Find out who and how is supposed to be responsible in the amazing world of QMS for medical devices. Learn about Quality Policy, and much more.

What is a quality manual, a medical device file, or document control – learn in Lesson 3.

Establish QMS, Clarify the structure, Support processes, Manage changes, Control outsourcing, and Validate software.

ISO 13485 for everyone - Simplified, explained, chapter by chapter - quality management system for medical devices! start with lesson 1.