All about Management Review in ISO 13485 – Lesson 7
How important is management review input and output while you build your medical device, read in this explained chapter of ISO 13485 – all about management review.
Responsibility, authority, and communication in ISO 13485 – Lesson 6
In every medical device company, there must be an organizational structure. In this article, you will learn about responsibility, internal communication and management representative according to ISO 13485.
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 medical device and company since the start. Find out more about key elements of Quality Planning.
What are the Management Responsibilities according to ISO 13485 – Lesson 4
Find out who and how supposed to be responsible in the amazing world of Quality management system for medical devices. Learn about Quality Policy, and much more.
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.
Custom Templates according to your needs
Freshly made custom issue forms as a new driving force of your workflow, now build and design forms based on your business needs, your own self-designed templates all per requirements of the standard ISO 13485: 2016.
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.
qmsWrapper’s growth on the market
Research on the global medical QMS software market in 2020 describes the supply and demand situation, market landscape, and competitive scenario. The analysis is focused on the current trends done under the supervision of business specialists.
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.
20 things you need to know about SOP for medical devices
SOP (Standard Operating Procedure) is required by the FDA, ISO, and other regulatory bodies. What SOP actually means? 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 medical device on US ground has to register with the FDA. In the flowing list, you will find key points that will help you to be aware of what awaits you.
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.
Cup of Joe #49 – Do You Need A Consultant?
With the ever-changing global marketplace of today, medical device companies are feeling the pressure of competition, the pressure to provide the most value and highest quality in their medical products.
It’s Official – MDR was postponed for a year
The European Parliament voted to suspend the implementation of the MDR by one year because of the coronavirus pandemic. This decision has been made.
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.