qmsWrapper Blog

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.

What are 5 the most frequently asked questions about ISO 13485? Check the questions, but find out all answers.

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.

How looks a working day for the qmsWrapper's Project manager? She is talking about her experience and much more, including a new announcement.

The main elements explained, all about Medical device class 1, from the EU and the US perspective including key differences and requirements.

Read Success Story - how The Wetling Company stayed compliant thanks to their choice when it comes to eQMS.

Research on the global medical QMS software market in 2020 describes the supply and demand situation. qmsWrapper plays a big role, find out why.

Basics that you should know when applying for premarket approval or 510(k). For each meddev explained including 'substantially equivalent’ devices and De Novo.

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.

Standard Operating Procedures are required by the FDA, ISO, and other regulatory bodies. What are the 20 things you need to know about SOP?