Take Back Compliance
The Art of Managing Through Quality
Control of nonconforming products in ISO 13485 – Lesson 18
The ISO 13485 covers all phases of the medical device lifecycle and one that must be covered is also the control of nonconforming products. It’s a product or a medical device that does not fulfill its specified requirements like customer or regulatory requirements. It’s important to be identified as soon as possible. Plus, ISO 13485:2016...
Monitoring and measurement according to ISO 13485 – Lesson 17
Monitoring and measuring activities of products are the necessary controls to ensure the medical device performs as intended – simplified ISO 13485, by qmsWrapper.
How ISO 13485 explains Measurement, analysis, and improvement – Lesson 16
In this lesson learn how to inspect product quality, determine the quality of your in-house processes, continuously improving methods of measuring customer satisfaction…
Control of monitoring and measuring equipment in the medical device industry – Lesson 15
Control of monitoring and measuring medical devices are one of the most important parts of the ISO 13485. Learn from qmsWrapper.
Medical device Production and service provision in ISO 13485 - Lesson 14
This section of ISO 13485 covers the different elements and resources that combine the realization processes to ensure conformance to medical device specifications.
What is Purchasing process in design and development in ISO 13485 – Lesson 13
ISO 13485 requires you to document your purchasing procedure to ensure purchased products adheres to stated purchasing information. What does that mean? Find out here.
From A to Z about Design and Development of medical device ISO 13485:2016 – Lesson 12
D&D as one of the most important sections of the ISO 13485 standard, explained to prevent the failure because if your medical device fails to meet regulatory design requirements, it won’t be able to reach the market.
Customer-related processes – Lesson 11
qmsWrapper explains how and why is important for you to keep to a high standard of your medical device or service that you offer to customers. About requirements and it’s a review of the way of communication.
What is considered by the planning of your product realization as per ISO 13485 – Lesson 10
Planning is part of success. And it refers to all phases of the life-cycle of your medical device. qmsWrapper guides you through the chapter of product realization of ISO 13485.
Work environment and contamination control according to ISO 13485 – Lesson 9
Work environment and contamination control are important and critical for effective and compliant medical device business run. qmsWrapper explains it all.
What is Resource Management in the medical device world – Lesson 8
Learn why ISO 13485 focuses on the improvement of Human Resources - the importance of the connection between qualified employees, the implementation of QMS, and maintenance of its effectiveness.
All about Management Review in ISO 13485 – Lesson 7
How important is management review input and output while you build your medical device, read in this explained chapter of ISO 13485 – all about management review.
Responsibility, authority, and communication in ISO 13485 – Lesson 6
In every medical device company, there must be an organizational structure. In this article, you will learn about responsibility, internal communication and management representative according to ISO 13485.
What is considered by QMS planning in ISO 13485 – Lesson 5
You will learn why without planning it’s impossible to build quality into your medical device and company since the start. Find out more about key elements of Quality Planning.
What are the Management Responsibilities according to ISO 13485 – Lesson 4
Find out who and how supposed to be responsible in the amazing world of Quality management system for medical devices. Learn about Quality Policy, and much more.
Essentials of Documentation requirements in ISO13485 – Lesson 3
What is quality manual, a medical device file, or document control – learn in lesson 3 that qmsWrapper have prepared for everyone who begins in the medical device world.
What are the General requirements in ISO 13485 – Lesson 2
Get familiar with the technical terms and general requirements of ISO 13485. qmsWrapper has adjusted it and simplified, so everyone can understand it. QMS establishment, structure clarification, etc. - all explained.
Understand ISO 13485 - Lesson 1
ISO 13485 for everyone - Simplified, explained, chapter by chapter - quality management system for medical devices! start with lesson 1.
5 FAQs about ISO 13485
What are 5 the most frequently asked questions about ISO 13485? Check the questions, but find out all answers.
Meet qmsWrapper’s Project Manager and find out more about new features
How looks a working day for the qmsWrapper's Project manager? She is talking about her experience and much more, including a new announcement.
All that you need to know about Medical devices Class I
Main elements explained, all about Medical device class 1, from the EU (CE mark perspective) and the US (FDA) perspective including key differences and requirements.
The Wetling Company’s eQMS-journey
Read Success Story - how The Wetling Company stayed compliant thanks to their choice when it comes to eQMS. By offering the latest cloud-based eQMS solutions, qmsWarpper is their support in quality.
Premarket approval (PMA) or notification (510k)
Basics that you should know when applying for premarket approval or 510(k). For each medical device explained including 'substantially equivalent’ devices and De Novo.
Post-market surveillance (PMS) of medical devices
As the medical device's complexity increases, post-market surveillance is getting more rigorous, so it can lead to earlier detection of potential failure at the end-user. To meet these needs, manufacturers should take a risk-based approach when considering clinical and medical device post-market surveillance requirements.