Companies involved in the designing and manufacturing of medical devices must be aware of the stringent regulations and restrictions imposed by government officials. Medical devices are used for a wide range of purposes and can mean a matter of life and death for individuals who rely on them. Medical devices are directed by the FDA in the United States, and firms must obtain ISO 13485 certification before designing or assembling them.
What is ISO 13485 certification?
ISO 13485 cover several safety requirements that ensure the quality and safety of medical devices. Although every country has laid out their own set of protocols for medical devices manufacturers, ISO 13485 remains the most widely accepted in the Medtech industry.
ISO 13485 was designed to fix the updated quality management system techniques, such as technological advancements and regulatory needs and expectations. The new protocols emphasise risk management and decision making along with the changes related to rising regulatory requirements for supply-chain businesses.
What does ISO 13485 certification mean for organisations?
Getting ISO 13485 certified is critical for businesses. Organisations of all sizes have realised its importance in saving time, money and bringing in a strong and efficient Quality Management System (QMS). Listed below are the few benefits of getting an ISO 13485 certification.
1. Enhances credibility: ISO 13485 is an internationally recognised quality standard for the MedTech industry. Certification in this standard is proof for the customers and clients that maintaining quality is a top priority for your business opening avenues for more opportunities.
2. Satisfies more customers: Changing customer expectations is one of the important reasons enterprises are more focused on ensuring quality. Adhering to ISO 13485 standards ensures a set of quality management principles are followed to guarantee customer satisfaction. Furthermore, it also ensures clients keep coming back to you and helps you to market your services to new customers.
3. Enhances employee engagement: When employees are involved in handling critical matters like ensuring quality management and enhancing processes, they will not only suggest the most valuable knowledge but also feel elated to invest in the company’s success. A highly engaged team ensures they understand their role in delivering high-quality products and services which leads to improved efficiency and productivity.
4. Scope for continuous improvement: When adopted as a part of the company culture, teams look at more scope for improvement in enhancing the processes. Every team member focuses on delivering high-quality products and improve services to satisfy maximum customers or clients.
5. Improves decision-making: The use of evidence-based decision making is one of the prescribed guidelines laid out in ISO 13485 certification. When proper data facts are used to decide, they tend to be more aligned with the company’s goals. Tracking data also enables the team to improvise at a given point in time to improve productivity and delivery quality products.
How MicroGenesis ensures a standard Quality Management process?
MicroGenesis is a certified ISO 13485 organisation which means we ensure the right people, process and technology to produce high-quality medical devices. With our 20+ years of expertise in the MedTech domain, we have always put forward our best plans and process to help design, test and run critical medical products. Our superior engineering practises, highly qualified teams ensure to deliver high-quality products in the market.
If you wish to know more about us, contact us: https://mgtechsoft.com/contactus
