Take Back Compliance
The Art of Managing Through Quality
What are the Management Responsibilities according to ISO 13485 – Lesson 4
Management has an absolute responsibility to foster the quality policy, confirm its alignment, and communicates the mission to employees. They have a responsibility to plan, delegate authority, and communicate effectively. They are also in charge of a periodic review of operations and improvement within the organization, known as the Management review. Management Commitment Some of the management...
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.
What is medical devices lifecycle
The Medical Device life cycle is considered a development of the product, from the very beginning to the end. What is the beginning, what is involved in the middle, and what is considered the end will be explained in this article.
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 medical devices and processes are essential for MedDev companies if they want to place their product on the European market. Audits are not used only for those reasons.
Basic Terms in Medical Device Industry
We can’t emphasize enough how important is to understand the language of medical devices. To meet the requirements and the Regulations it’s essential to understand what is meant by keywords and phrases.
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
qmsWrapper team was interviewing one of our Users who become qmsWrapper Consultant – 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 Medical Device. And we all know that every beginning is hard. Therefore, for startups, it’s quite a challenge. But fear not. More you know, 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
Risk Analysis Module becomes a very important update, next to other features: Traceability Matrix, Process Engine, and Jira integration. 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
As a medical device manufacturer which wants to place its product on the European market, you must be aware of all requirements to do so. Of course, one of the first things, you need to comply with Europe’s Medical Device Regulation (MDR).
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 inspectors/auditors the connection between the requirements, its design inputs, validation and verification, risk analysis, etc.
Jira is now “wrapped” with qmsWrapper
The combination of JIRA brings a system in which Medical Device Startups are able to track, manage and organise all CE Technical Files and FDA Design History Files, and do it in the most effective manner possible.