Even though the new medical device regulation EU 2017/745 has been postponed for a year, changing existing quality management systems (QMS) or building a new one in case of a previously lower risk class and for new ventures became a pressing issue for many entrepreneurs and quality mangement representatives. For new QMSs, it might be especially time-consuming to both prepare for the new medical device regulation EU 2017/745, but also still support the medical device directive 93/42/EEC as long as it is not yet replaced.
The current regulatory requirements on new medtech startups, at least in my opinion, actively prevent innovation in medical devices and medical software: While both 93/42/EEC and EU 2017/745 built a harmonized legal basis to develop new medical innovation, the approach of certifying against norms (ISO 13485) that each company has to implement via their own effort or consulting services is highly inefficient. A software startup might (understandably) not care that much about documented purchasing processes or the required documentation for hiring their team, while an efficient and compliant software development process is vital to their future success.
In other domains, reference models like the IT Infrastructure Library (ITIL) in IT Service Management (ISO 20000) or the Supply-Chain Operations Reference (SCOR) model show that organizations do not always need to reinvent the wheel to apply best practices. Medtech companies do not yet have the luxury of picking predefined models and just extending them with their own USP. Reducing the initial effort to zero will most likely not be feasible, but reducing it drastically is.
Hence, in the following months, I’ll post many articles describing relevant processes for a medical software manufacturers. The content will be collected in a coherent form as an ebook that will remain free (and work-in-progress states will be available with new blog posts), probably a print version as soon as the collection is “finished”, and document templates that will be included in paid plans of Pertuniti as well as non-editable PDFs. The book will be english, while I try to make most blog posts multilingual. Obviously, the processes will be tailored to Pertuniti in regard to efficient document management, data management, and automation.
The ultimate goal is that building a tailored QMS for medtech companies requires less effort while performing quality-related tasks in Pertuniti to enable automation, remain flexible, and provide full transparency for your teams as well as auditors.