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.
Essentials of Documentation requirements in ISO13485 – Lesson 3
You will see in the end, it’s all about documentation. If not in this part then by the end you will perceive the importance of...
Policy: establishing and communicating the quality policy – Lecture 4
Lecture summary: The quality policy is a document where you should state your commitment to your improvement You need to apply it throughout the organization...
What are the General requirements in ISO 13485 – Lesson 2
Every ISO standard has the system of requirements and each one of them is described in segments. In general requirements, it’s established what is meant by: Developing and...
Organizational Roles, Responsibilities, and Authorities – Lecture 5
Lecture summary: Top Management is by definition a person or group of people who instruct and control an organization at the highest level (within the...
Understand ISO 13485 – Lesson 1
Let’s say you have an idea of placing an innovative medical device on the market. That’s great, but you already know that going from idea to actual...
5 FAQs about ISO 13485
1. What is an ISO 13485? ISO 13485 is an international standard for establishing quality management in the medical device industry. It is an effective explanation...
Meet qmsWrapper’s Project Manager and find out more about new features
qmsWrapper is a successful company promoting the organizational framework that provides structure to the processes, policies, procedures, and resources to implement the Quality Management System for medical device startups....
Planning: Actions to address risks and opportunities – Lecture 6
Lecture summary When planning how to address risks and opportunities the best way is risk-based thinking Risk-based thinking will guide your top management to make...
All that you need to know about Medical devices Class I
Medical devices are devices whose purpose is to benefit patients. They are usually used by doctors and healthcare providers to help them diagnose and treat...
