qmsWrapper now covers and supports ISO 9001:2015
Recognizing the client's needs and their specific requirements, somehow just imposes for qmsWrapper to expand its capacities and dominate ISO 9001:2015 market.
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 adhere to the stated purchasing information. What does that mean?
From A to Z about Design and Development of medical device ISO 13485:2016 – Lesson 12
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.
Customer-related processes – Lesson 11
What is important when determining requirements, when it's time to review, and how to communicate with your customers?
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 meddev. 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
The importance of the connection between qualified employees, the implementation of QMS, and the 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 meddev, read this explained chapter of ISO 13485 – all about management review.
Responsibility, authority, and communication in ISO 13485 – Lesson 6
In every meddev company, there must be an organizational structure. Learn about responsibility, internal communication, and management representative.
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 meddev and company from the start.
What are the Management Responsibilities according to ISO 13485 – Lesson 4
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.
Essentials of Documentation requirements in ISO13485 – Lesson 3
What is a quality manual, a medical device file, or document control – learn in Lesson 3.
What are the General requirements in ISO 13485 – Lesson 2
Establish QMS, Clarify the structure, Support processes, Manage changes, Control outsourcing, and Validate software.
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.
Custom Templates according to your needs
Create your own forms to collect data and generate quick reports from it. Free templates are available, so you can customize them to suit your needs.
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
The main elements explained, all about Medical device class 1, from the EU and the US 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.
qmsWrapper’s growth on the market
Research on the global medical QMS software market in 2020 describes the supply and demand situation. qmsWrapper plays a big role, find out why.
Premarket approval (PMA) or notification (510k)
Basics that you should know when applying for premarket approval or 510(k). For each meddev explained including 'substantially equivalent’ devices and De Novo.
Post-market surveillance (PMS) of medical devices
As MedDev's complexity increases, post-market surveillance is getting more rigorous, so it can lead to earlier detection of potential failure at the end-user.
20 things you need to know about SOP for medical devices
Standard Operating Procedures are required by the FDA, ISO, and other regulatory bodies. What are the 20 things you need to know about SOP?
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.