The course will present the requirements of the standard EN ISO 13485:2016 for the quality management system in the production of medical devices (and related services) and related legislation applicable to the field of medical devices.
Medical devices placed on the market must comply with the Regulation (EU) 2017/745, which applies to each individual product of a particular type or model and it has in certain areas has a significant impact on the QMS, the devices themselves, the manufacturers, the importers and the distributors of medical devices.
Regulatory requirements for medical devices on American, European or other global markets differ. Prior a successful sale on US market the medical device shall be registered (e.g. procedure acc. 510(k)), as well as quality system regulation principles acc. 21 CFR 820 shall be respected by medical device manufacturer.
In order to prove the conformity of a programmable active medical device according to medical directives, it is necessary to provide compliant software, which must be safe and effective.
Biocompatibility of medical devices is an important characteristic of safe and compliant medical devices. The main steps for ensuring biocompatibility are specified in ISO 10993-1 standard.
Sterilization is one of the key processes in the production of sterile medical devices. Among the different sterilization types, each has its advantages and disadvantages. Evidence of successful sterilization is important and expected when demonstrating conformity with regulatory requirements.