qmsWrapper Blog
![What is considered by QMS planning in ISO 13485 – Lesson 5 What is considered by QMS planning in ISO 13485 – Lesson 5](/files/Pictures/blog/ISO_13485/iso_13485_5/ISO13485_lesson5_cover_small.jpg)
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 What are the Management Responsibilities according to ISO 13485 – Lesson 4](/files/Pictures/blog/ISO_13485/iso_13485_4/ISO13485_lesson4_cover_small.jpg)
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 Essentials of Documentation requirements in ISO13485 – Lesson 3](/files/Pictures/blog/ISO_13485/iso_13485_3/ISO13485_lesson3_cover_small.jpg)
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 What are the General requirements in ISO 13485 – Lesson 2](/files/Pictures/blog/ISO_13485/ISO_13485_2/ISO13485_lesson2_cover_small.jpg)
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 Understand ISO 13485 - Lesson 1](/files/Pictures/blog/ISO_13485/iso_13485_1/ISO13485_understand_cover_small.jpg)
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 5 FAQs about ISO 13485](/files/Pictures/blog/ISO_13485/ISO_13485_0/FAQ_ISO13485_cover_small.jpg)
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 Meet qmsWrapper’s Project Manager and find out more about new features](/files/Pictures/blog/Milica_interview/Milica_interview_cover_small.jpg)
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 All that you need to know about Medical devices Class I](/files/Pictures/blog/Medical_dev_class_1/Medical_Class_1_cover_small.jpg)
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 The Wetling Company’s eQMS-journey](/files/Pictures/blog/Anders/Anders_1_cover_small.jpg)
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) Premarket approval (PMA) or notification (510k)](/files/Pictures/blog/Premarket/Premarket_cover_small.jpg)
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 Post-market surveillance (PMS) of medical devices](/files/Pictures/blog/Post-market-surveillance/Post-market-surveillance_cover_small.jpg)
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 medical devices lifecycle](/files/Pictures/blog/Lifecycle_Medical/Medical_Device_Lifecycle_cover_small.jpg)
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 How to do an Offsite Audits](/files/Pictures/blog/Offsite_audit/Audit_1_cover_small.jpg)
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 Extraordinary circumstances require extraordinary measures-Offsite auditing](/files/Pictures/blog/offset_auditing/extraordinary_offsite_auditing_cover_small.jpg)
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 Basic Terms in Medical Device Industry](/files/Pictures/blog/MedDev_terms/Medical_terms_blog_cover_small.jpg)
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 QMS Manager role in MedDev industry](/files/Pictures/blog/qms_manager_job_description/qms_manager_role_description_blog_cover_small.jpg)
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 qmsWrapper’s successful User](/files/Pictures/blog/Interview_Emma/Client_interview_feedback_emma_blog_cover_small.png)
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 10+ essential things what MedDev startups must know](/files/Pictures/blog/Startups_must_know/Startups_must_know_blog_cover_small.jpg)
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 Enterprise-grade Processing Engine](/files/Pictures/blog/Process_Engine_2020/Proces_engine_NEW_cover_small.jpg)
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 New Risk Module supports risk-based design](/files/Pictures/blog/New_risk_Module/Risk_Module_NEW_cover_small.jpg)
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 The Ultimate Content List of Technical File for CE marking](/files/Pictures/blog/TechnicalFile_blog/Technical_File_what_cover_small.jpg)
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 8 things to know about CE approval process for Medical Devices](/files/Pictures/blog/8_Things_for_CE/CE_mark_8_blog_cover_small.jpg)
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 things you must know about CE Mark](/files/Pictures/blog/CE_mark/CE_HOW_WHAT_WHY_small.jpg)
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 A new Traceability Matrix so powerful, it becomes the products dashboard](/files/Pictures/blog/traceability_matrix/traceability_matrix_cover_small.jpg)
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.
![Jira is now “wrapped” with qmsWrapper Jira is now “wrapped” with qmsWrapper](/files/Pictures/blog/Jira/wrapp_jira_cover_small.jpg)
Jira is now “wrapped” with qmsWrapper
qmsWrapper has become the right choice for Jira users who need Quality Management System.