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.
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.
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.
What is medical devices lifecycle
What is the beginning of the medical device lifecycle, what is involved in the middle, and what is considered the end?
How to do an Offsite Audits
An offsite audit is the same as an on-site QMS audit, but the auditor engages with you via technology.
Extraordinary circumstances require extraordinary measures-Offsite auditing
Certain audits of meddev and processes are essential for companies if they want to place their product on the European market.
Basic Terms in Medical Device Industry
To meet the requirements and the Regulations it’s essential to understand what is meant by keywords and phrases in the medical device industry.
QMS Manager role in MedDev 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 qmsWrapper’s successful User
Interview with one of the qmsWrapper Consultants – Emma Fortin. Read what she had to say about software and collaboration with the Support team.
10+ essential things what MedDev startups must know
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.
Enterprise-grade Processing Engine
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 New Risk Module supports risk-based design
The Risk Analysis Module becomes a very important update. Changes will make Risk Assessment much easier and clearer.
The Ultimate Content List of Technical File for CE marking
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.
8 things to know about CE approval process for Medical Devices
Determination EU Medical Device Directive which applies, Device Classification, Implementation of QMS, Technical File Preparation, etc.
5 things you must know about CE Mark
5 Answers on Most Important Things You Should Know About CE Mark.
A new Traceability Matrix so powerful, it becomes the products dashboard
qmsWrappers Traceability Matrix clearly demonstrates to auditors the connection between the requirements, its design inputs, validation and verification, etc.