Articles (Blog)
Medical Device QMS Blog
Practical guidance for MedTech teams navigating quality, compliance, and regulatory requirements.
Explore insights on medical device QMS, ISO 13485, risk management, FDA, EU MDR, traceability, CAPA, and other topics involved in building and maintaining a compliant medical device quality system.
Gap analysis in QMS
Perfect, now when you have learned about the ISO 13485 standard with the help of 20 lessons explained on this website, now you are ready to implement...
The library – feature for the rest of the company
A library is an integral part of any community. They provide information and resources. So why not one in qmsWrapper, more than storage it’s a...
All about Management Review in ISO 13485 – Lesson 7
The main goal to conduct a management review is to allow top management from time to time to examine the quality management system. That is done...
Introduction (Scope, normative references, terms, and definitions) – Lecture 1
Lecture summary: By implementing ISO 9001 standard you are showing to the world you care about your customers You need to follow a set of...
Responsibility, authority, and communication in ISO 13485 – Lesson 6
Responsibility and Authority Top management is in charge of appointing responsibilities to other staff and management to ensure that the QMS is being met. They also need to...
What is considered by QMS planning in ISO 13485 – Lesson 5
This part of the standard explains why is planning so influential. Because without planning it's impossible to build quality into your medical device and company since the...
Understanding the organization and its context – Lecture 2
Lecture summary: Understanding the context of your organization is key to a correct business strategy You need to consider only issues that can affect customer...
Leadership and commitment – Lecture 3
Lecture summary: Top management will have to supply evidence for its actions and improvements of QMS if they want to prove their commitment ISO 9001...
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,...
