## 2 The Steps of Medical Device Development in General
### Quality Management and Regulatory  
A quality management system (QMS) is required for medical device certification, preferably according to ISO 13485. Compared to the technological point of view, the QMS focuses on reducing risks and ensuring that the processes are foreseeable and adequately documented, and thus controllable throughout the complete lifecycle of the device.  
The quality management and regulatory steps are the following:  
1. Complying risks and hazards and their management according to ISO 14971.
2. Classification of the device according to the applicable medical device regulations (MDR), based on the markets that are planned to be accessed. In our example, the EU is the main focus. The classification is based on the risks relating to the device--there are three main classes, Class I, Class II and Class III. This determines if the device needs to be sterile, and gives a basic idea on the magnitude of the costs and complexity of the device.
3. The essential requirements (general safety and performance according to the new MDR) of the devices and all the processes that are in connection with the device are regulated by standards and it is required to be gathered according to the applicable medical device directives (MDD) and regulations (Table 2). Essential requirements are divided into two parts--Part I: general requirements and Part II: requirements for design and construction. A checklist can be obtained through the Official Journal of the European Union to identify the applicable standards. All the process validations need to be performed that are required in the applicable standards and regulations after the design and development phase is over.
4. Biological evaluation needs to be performed according to ISO 10993-1 to ensure from biological and toxicological aspects, and that the use of the device is safe for both the patient and the users (Table 3).
5. Accomplishing clinical evaluation. Clinical evaluation is either the analysis and demonstration of equivalence [39] using publicly available clinical data regarding the clinical, technical and biological characteristics of the medical device compared to relevant medical devices on the market, or performing a clinical investigation [40] to determine its clinical safety and effectiveness, that is stated in the intended use.  
\begin{table}
\begin{tabular}{c l} \hline \hline
**Standard** & **Regarding Subject** \\ \hline ISO 13485:2016 & Medical Devices—Quality Management Systems—Requirements for Regulatory Purposes \\ \hline ISO 14971:2007 & Medical devices—Application of risk management to medical devices \\ \hline ISO 11607-1:2019 & Packaging for terminally sterilised medical devices—Part 1: Requirements for materials, sterile barrier system and packaging systems \\ \hline ISO 11607-2:2019 & Packaging for terminally sterilised medical devices—Part 2: Validation requirements for forming, sealing and assembly processes \\ \hline EN 868-5:2018 & Packaging for terminally sterilised medical devices—Part 5: Scalable pouches and reels of porous material, and plastic film construction—Requirements and test methods \\ \hline EN 556-1:2002 & Sterilisation of medical devices—Requirements for medical devices to be designated \\  & STERILE- \\  & Part 1: Requirements for terminally sterilised medical devices \\ \hline EN ISO 80369-7:2016 & Conical fittings with a 6\% (Luer) taper for syringes, needles and certain other medical \\  & equipment—Part 1: General requirements \\ \hline EN ISO 80369-7:2016 & Conical fittings with a 6\% (Luer) taper for syringes, needles and certain other medical \\  & equipment—Lock fittings \\ \hline ISO 10993-1:2018 & Biological evaluation of medical devices—Part 1: Evaluation and testing within a risk \\  & management process \\ \hline \hline \end{tabular}
\end{table}
Table 2: Essential requirement checklist.