How to implement ISO 13485 for software Medical Device Company? A review

ISO 13485 represents the requirements for laying down a comprehensive Quality management system for the Design and Manufacture of Medical Devices. It is basically an all-encompassing standard that broadly covers high- level considerations for a manufacturer to set up a Quality management system.

In case of Software as a medical device (SaMD) the manufacturers could be in a fix as to how to apply the standard considering their huge design process, very minimal production and large maintenance phase. So fine tuning of the standard is for our application is needed.

As per the ISO 13485 Standard all the clauses are mandatory other than clause 7 which falls into the discretion of the manufacturer whether to apply it or not. Other than that it is required for every Medical Device Manufacturer to put in place all that is required for Clause 4-6 and 8 and the standard does not differentiate between a software based medical device and others.

The purchase control would not be a major area of focus for Software Medical Device Companies as there might not be much purchase work involved other than the basic Hardware and minimal software to work on. Similarly, a work environment might not be important as it focuses more on the cleanliness of the place which is of foremost importance where manufacturing or sterilization is involved. But since these are mandatory procedures the Manufacturer needs to put in place at least a simple procedure.

Production, CAPA, Change Control, Post Market Surveillance, Customer Communications are all important and needs to be incorporated with care.

Procedures involving Sterilization, Contamination control, Active Implantable devices can be excluded with a justification. In case of Control of monitoring and measuring devices, the manufacturer needs to assess the usage of measurement devices for validation and other purposes and decide on the incorporation of the procedure in the Quality System.

The software development needs to be in line with IEC 62304 which covers the entire lifecycle. Design is mandatory to be incorporated. Thus to conclude, support activities such as Purchase, Work environment can be minimal while importance needs to be given to Design and production while focus on Post production phase helps the company with more bug fixes and feature addition.

The author recommends you to Contact I 3 Consulting for further information and expert knowledge on Medical devices, Software and CE marking.

Jeyadevi Rajesh is a regulatory specialist at I 3 Consulting, a leading firm specialising in CE and Fda submssions. Contact jr@i3c.com for further information.