qmsWrapper Blog

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.

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.

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.

What is the beginning of the medical device lifecycle, what is involved in the middle, and what is considered the end?

An offsite audit is the same as an on-site QMS audit, but the auditor engages with you via technology.

Certain audits of meddev and processes are essential for companies if they want to place their product on the European market.

To meet the requirements and the Regulations it’s essential to understand what is meant by keywords and phrases in the medical device industry.

A QMS manager safeguards that standards are met throughout all processes of the company, from customer relations to manufacturing processes and all in between.

Interview with one of the qmsWrapper Consultants – Emma Fortin. Read what she had to say about software and collaboration with the Support team.

It is not easy to build a MedDev, and we all know that every beginning is hard. For startups, it’s quite a challenge. The more you know, the easier it is.

Massive update of the year is happening and qmsWrapper’s Users will be thrilled to find out what is new in one of the 4 upgrades – Process Engine.

The Risk Analysis Module becomes a very important update. Changes will make Risk Assessment much easier and clearer.

Some general details of the kind of information which will be required in the Technical File. As a general guide, the following items should be included.

Determination EU Medical Device Directive which applies, Device Classification, Implementation of QMS, Technical File Preparation, etc.

5 Answers on Most Important Things You Should Know About CE Mark.