December 26, 2022

A lean and efficient Quality System for an SaMD


Solutions that were cost-effective and efficient both in the short and long term


A Switzerland-based company that developed an analysis software to assess various physiological parameters obtained by wireless remote monitoring was in need of a Quality Management System (QMS) for their Software as a Medical Device (SaMD). The company (herein also referred to as Client) hired Elexes to help set up their QMS so that the product they put on the market, after appropriate approvals, is continually safe and effective for its intended use.


  1. Requirement of a customized QMS 

Since the Client was located both out of Switzerland and the United States, the Client wanted a QMS which can meet both the FDA and European requirements. Additionally, the Client wanted a structure of the QMS which was lean and common between the two sites (Switzerland and the United States). 

  1. Absence of DHF ownership

The Client was unaware of how to start a DHF file and how to ensure different process owners within the company are aware of their responsibilities as it relates to the maintenance of a DHF. 

  1. Lack of ownership of maintaining long term compliance requirements 

The Client was not only seeking assistance on setting up a QMS, but wanted hand holding for several months until they felt comfortable in having their in-house team take over the regular maintenance work with Elexes being there in a supporting capacity only. 


  1. Lean QMS structure 

Elexes spent time with the stakeholders at the Client’s and understood the goals of the company and what they were looking to achieve over the coming years. Considering all these and other practical implications, Elexes helped the Client set up a divisional QMS structure with no redundancies between the US and the Switzerland sites. Elexes emphasized upon and helped the company set up a customised Software Development Life Cycle (SDLC) procedure, which was an integral part of the QMS, especially since the Client was developing an SaMD. 

  1. Defined DHF ownership

Elexes guided the Client with the DHF compilation and took ownership of drafting many parts of the DHF; thereby allowing the Engineering and R&D team to focus on product development. In parallel, Elexes worked with other process owners to help them understand how their work output is important from a QMS stand point. Over time the process owners ensured that the different elements of DHF, which were intended to be kept up to date, were kept such through effective cross functional interactions. 

  1. Continued compliance 

Elexes not only helped set up a QMS but assisted in maintaining it. Elexes provided support to the Client for every certification, surveillance and recertification audit. Elexes performed internal audits and provided training on QMS updates on an ongoing basis. Elexes worked with the Client’s management team to build a culture where quality is given importance. 


Elexes helped the Client by:

  • Setting up a lean QMS between two sites with least redundancies 
  • Structuring an SDLC procedure per the Client’s preferred software development methodology and IEC 62304 and other relevant standards 
  • Creating a robust DHF that got through every audit and FDA inspection
  • Ensuring QMS is compliance with the US and other international requirements 
  • Obtaining an ISO 13485 and MDSAP certification
  • Building a “quality focussed” culture

Key Takeaway 

All medical device manufacturers should have an appropriate quality management system. It ensures that a workplace is focused on delivering the safest and most effective devices. A robust QMS also acts as a gateway to many regulatory clearances and approvals, since all the documents shall be always readily available.

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