Medical Device Quality Management System Solutions
Achieve Regulatory Compliance with Ideagen’s Solutions
Our medical device quality management system solutions support key business processes, ensuring quality, reliability and safety are achieved throughout a product’s lifecycle.
- Modernise and strengthen your quality management system
- Ease compliance with standards and regulations
- Create a culture of reporting and safety
- Substantially improve operational performance and efficiency
- Control and protect reputation and brand
- Help anticipate and prevent problems and issues
Achieving and maintaining compliance with the FDA’s 21 CFR 820 and Part 11, ISO 13485, or ISO 14971 is of vital importance to medical device companies in demonstrating the quality and safety of their products. In addition, the current EU Medical Device Directive (MDD) is transitioning to the Medical Device Regulation (MDR.) Devices placed on the market must meet these new requirements, and time to market may increase as a result.
Ideagen's products and services cover this business need and deliver operational excellence in advanced manufacturing with an effective medical device quality management system.
"Q-Pulse makes it easier to tie information gathered from each site together in order to look for issues, synergies or trends to see if there are any opportunities for improvement and identify best practice.
— Mike Gordon, Group Operations Director at Omega Diagnostics
EU Device Regulations
The new Medical Device Regulation (MDR) is replacing the current Medical Device Directive (MDD) in May 2020 and forms the biggest change to EU medical device regulations in the past 20 years. Any medtech organisation wishing to sell in the EU market must comply with MDR. The purpose of the regulation is to improve product safety and performance, with an increased focus on quality and maintenance. In order to do this, it will require closer evaluation throughout the lifecycle of a product and traceability of the process.
MDR builds on the foundation of standards such as ISO 13485 and 21 CFR 820 to set new standards for selling medical devices within the EU market. It ensures the safety of the products and introduces the idea of risk basis in quality management.
Access your free Toolkit which includes a whitepaper, customer insights, and a checklist which will help you understand how Ideagen's software can help you comply to the upcoming MDR.
In Vitro Diagnostic Medical Device Regulation (IVDR) will come into effect in May 2022, applying to all in vitro diagnostic medical devices. This regulation will re-define what an IVD is and improve the classification and regulation of them. It is replacing the older IVD standard in order to protect the safety of patients and improve the regulations for new products.
A robust and accessible quality management system is required in order to comply with ISO 13845, MDR and IVDR.
ISO 13485 is an industry specific standard for medical device manufacturers, giving detailed guidelines for the required quality management system. Compliance with this global standard enables medtech companies to implement more robust processes and streamlines their procedures to ensure quality, reliability and safety are achieved throughout the lifecycle of their products.
Not only will this ensure compliance, but it will accelerate time to market and mitigate future risk, enhancing the overall quality of a product’s lifecycle.