Software as a Medical Device MDR Services

Assure medical device compliance with the Medical Device Regulation (MDR) with approved and notified body services from SGS.

Many medical devices rely on software to ensure efficacy, safety and quality. The MDR has special technical restrictions for software, irrespective of how it is used.

Software in the medical device industry represents a rapidly expanding area in health care. Digital healthcare platforms are constantly evolving and increasingly play a vital role in all areas of a patient health, from diagnosis and treatment to monitoring.

As an integral part of medical devices, software may be used to manufacture or maintain a device, or the software itself can be a medical device. In all cases, the software must meet certain requirements and comply with the regulations. Therefore, it is important to determine which rules apply.

Why choose SGS to certify your software as a medical device (SaMD)?

We provide the unrivaled expertise you need for a smooth certification process. We are:

A Notified Body in Belgium (1639)
A Notified Body in Finland (0598) for clients specifically needing Software as a Medical Device (SaMD) certification
An Approved Body for the UK Conformity Assessed (UKCA) mark (AB0120)
An Approved Auditing Organization (AO) for the Medical Device Single Audit Program (MDSAP)

In addition, we offer:

Integrated and/or combined audit solutions to help you save time and money
Assessment and certification services for specific medical device requirements
A dedicated account management team to ensure your certification project gets the relevant support
Global resources and a local presence – our people speak the language, understand the local market culture, and operate globally

Why SGS?

We are the world’s leading provider of testing, inspection and certification services. We are recognized as the global benchmark for sustainability, quality and integrity.