Skip to content

The Importance of Meeting Quality Requirements in the Medtech Industry

When choosing a development and production partner to manufacture medical devices, there are certain areas that must not be compromised with. You should look for a partner with a quality mindset, that focuses on patient safety, product quality and compliance. According to us, to comply with applicable rules and regulations goes without saying.   

What does insufficient quality mean for the end user/patient?

Every day, numerous medical devices are used in health care facilities, and elsewhere, all over the world. Most devices are quite simple, while others are complex and combine different technologies. Defects or disturbances in the functions of medical devices may expose patients to serious risks. This is particularly true for devices which transfer energy or pharmaceuticals to patients, e.g infusion pumps, or devices which sustain or support vital functions, e.g pacemakers. Nonetheless the safety standards must be high for all medical devices. The devices shall be safe and reliable and well suited for their intended purposes.

Medical device having defects or malfunctions could lead to severe consequences

Deviations from expectations and claims could be a threat to patients’ health in terms of dissatisfaction, pain, discomfort and suffering. It could also lead to more serious consequences, such as injury, sickness and death. A structured and controlled way of designing, producing and distributing medical device products is a must. This is to ensure that the products are safe, and by that said, free from unacceptable risks for persons, property or environment. This structured way of working is described in several laws and regulations, as well as standards and guidelines.

The medtech industry is subject to extensive rules and regulations

To avoid accidents and risking the patients’ health, there are a number of different standards and regulation systems to follow. U.S. Food and Drug Administration (FDA) has implemented Quality System Regulation, (QSR) to ensure product performance and safety. Europe’s regulations are published in the Medical Device Directive. The aim of these rules, as regulations, is to ensure a high level of protection for human health and safety. In Europe, the standard ISO 13485 complements the Medical Device Directive, and describes the requirements for a comprehensive quality management system for the design and manufacturing of medical devices.

The regulations exists primarily for enabling patient access to high quality, safe and effective medical devices, and restricted access to those products that are unsafe or have limited clinical use. When appropriately implemented, the regulations ensures public health benefit and the safety of patients, health care workers and the community. Additionally, there are several recognised guidance documents published that support the medtech industry to comply with the rules and regulations.

High demands on development and production partners

When working in the medtech industry, it is important to choose a development and production partner that live up to the high demands that are required. A development and production partner needs to be aware of all the various applicable laws and standards, and manufacture the medical devices accordingly. Policies and procedures shall be established in line with the defined rules and regulations, and employees shall follow these policies and procedures.

In my opinion, working with medical devices is a trusted job that all must take “pride” in. To have a quality mindset is the prerequisite for patient trust, which includes patient safety, compliance and product quality.

Our values at Elos Medtech

At Elos Medtech, our commitment is to never compromise on safety, compliance or quality, of our products and services. This requires everybody to be engaged, to understand their responsibility in achieving our quality objectives and to be empowered to take action in order to protect our patients and customers. Our founded values at Elos Medtech help us to keep our promises and be precise in our work; passion, trusthworthy and result-oriented are words that describe our way of thinking and acting in everything we do.

Elos Medtech ensure quality to meet the expectations and needs of all stakeholders

This means that we will;

  • Never compromise on patient safety and quality
  • Respect and comply with all statutory and regulatory requirements or other provisions applicable for our operations
  • Continuously challenge ourselves through the review of our quality management system, quality objectives and results, to sustain a high quality and to make improvements when needed
  • Promote quality awareness throughout the company and the entire supply chain

I hope you found this article rewarding. Please don’t hesitate to visit our website or contact me with any further questions.