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 documenting practically everything. Everything has to be documented, so it can be tracked. In this QMS world, there is an…
Lecture summary: A quality policy is a document that provides guidelines, intentions, and goals of your company referring to quality intentions. When creating one, you will describe your company’s strategy and policies that will serve various interested parties. Make it to be a more practical…
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: QMS establishment The key point with QMS establishment is to be done in accordance with the requirements described in this exact standard. And by…
Lecture summary: Organizational structure The organizational structure is the definition of hierarchy in the organization and relates to the nature of the organization. Through the structure, you need to describe all the functions, roles, and relations in your company. Although there are no specific requirements…
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 realization is not the whole picture, just the tip of the iceberg. Yes, there is a much larger part below…
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 to meet the comprehensive requirements for a QMS in the medical device industry. The other well-known QMS requirements to follow…
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. Behind every successful company stands the skillful team. But the key role of such a team that leads to success is…
Lecture summary This part of the ISO 9001 standard highlights risk-based thinking. Why? Because it will help you by directing you to look and see opportunities, to address risks that will guide you to better and safe decisions. Risk-based thinking is a ground base for…
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 patients. Despite its usefulness, they can pose a potential risk for human health. Therefore, they must be proved safe and…
We live in a time of technological evolution and the medical device industry is no exception. Technology advances day-by-day. The Wetling Company, with its revolutionary new wound-healing technology, is one such example. Their mission is to ease ailments caused by chronic and acute wounds, through a patented and…
