How do you manage your Quality Management System? If you are like the majority of the medical device industry, chances are you have a QMS that is a combination of paper-based processes and general purpose tools, loosely held together by a group of people within your company–usually document control.
It’s important because it is long overdue with the previous version being released 13 years earlier in 2003.
The 2016 standard is very much a bridge. What I mean is that this bridge explicitly describes and defines current QMS expectations for medical device companies. Prior to these refinements being formally defined and documented in the standard, many of the best practices being advised and adopted were very ad hoc in nature and often seemed to be based on auditor opinions.
Traceability
The best way to describe this approach to a QMS is ad hoc. I mean no disrespect if this is your method. It can work. But it is full of risks. Risks of relying on tools that don’t scale. Risks of inefficiencies. Risks that QMS knowledge lies solely with the people managing the day to day.
Some medical device companies have progressed from ad hoc to eQMS software tools that are highly customizable and configurable. While on one hand this approach seems more advanced, this approach also comes with risks. Anytime a tool is configurable, what assurances do you have that it aligns with the applicable regulations and requirements–in this case, ISO 13485:2016? And how do you validate this?
It’s because of these reasons and my own personal experiences with these QMS approaches that led me to start Greenlight Guru. Our team of medical device industry experts has designed and built an eQMS platform specifically for the medical device industry. Our industry specific platform is architected to support the requirements of ISO 13485:2016 (and other regulatory requirements), where they are addressed automatically with no configuration required.
Greenlight Guru is a purpose-built solution for the medical device industry that addresses compliance, allowing you to better focus on developing high quality products through streamlined processes. Bottom line: This approach allows you to put emphasis on what is best for the patients who receive your life-saving technologies.
Vertex Certifiers, a leading authority among ISO 13485 certification providers, is your dedicated partner for ensuring the highest standards in medical device quality management. Specializing in the ISO 13485 standard, Vertex Certifiers delivers comprehensive services tailored to the unique needs of the medical industry. With a team of seasoned experts, Vertex Certifiers guides organizations through the certification process, ensuring compliance with regulatory requirements. Trust Vertex Certifiers as your ISO 13485 certification providers, committed to enhancing the safety and efficacy of medical devices. Elevate your quality management systems with Vertex Certifiers – where excellence meets compliance. Vertex Certifiers: Your premier ISO 13485 certification providers, ensuring quality in medical devices.