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Consulting & Auditing

Connected Medical Devices, SaMD & IoMT

Oriel STAT A MATRIX offers full life cycle quality and regulatory support for manufacturers of digital medical technology.

Consulting

From hospital equipment connected to Wi-Fi to implants that are Bluetooth-enabled, many of today’s medical devices incorporate software connected to networks. Most require connectivity to operate and some collect confidential patient and diagnostic data.

Types of Devices Include:

  • Medical devices & In-Vitro Diagnostic (IVD) devices and accessories
  • Software as a Medical Device (SaMD)
  • Internet of Medical Things (IoMT) devices
  • Medical Device Data Systems (MDDS)

Full Life Cycle Regulatory Support for Connected Medical Devices

From development through end of life, special considerations must be made for the unique risks and challenges posed by integrating software into your device. Whereas previously, we could expect the operating environment and associated risks to remain relatively static, now technology changes at warp speed which means our devices will encounter scenarios we cannot predict. Oriel STAT A MATRIX provides full regulatory lifecycle support from the design phase all the way to post-market surveillance and product updates to devices in the field. We will help ensure that you meet today’s regulatory requirements and rise to the challenges of tomorrow.

Ways We Can Assist MedTech, SaMD & IoMT Device Manufacturers

We offer a wide array of QA/RA training and consulting services specifically for medical device and IVD manufacturers. Some of our most popular classes and services among medical technology companies include:

Training Courses

Classes are available as in-person or virtual instructor-led trainings. Select a course to learn more or to register.

Course Name Public Private
Medical Device Cybersecurity Risk Management Standards & Regulations Training Course
Medical Device Software Development, Verification, and Validation Training (IEC 62304 and ISO 13485:2016)
New!
Medical Device Software Regulations and Standards Training
Medical Device Data Integrity and FDA 21 CFR Part 11 Compliance Training
New!
Medical Device Software Development Life Cycle Training
New!
QMS Software Validation Training for Medical Device Companies Meeting FDA and ISO 13485 Requirements

If your company makes connected devices, you know cybersecurity is paramount. Click to learn more.

Learn how to apply US and international regulatory requirements and standards for the design and validation of medical device software. Click to learn more.

This course provides a foundation for understanding the regulatory landscape for software development. 

Make sure your organization's electronic records meet US 21 CFR Part 11 requirements. 

This course provides an in-depth look at the software development life cycle, using the IEC 62304:2006 as a basis for the course discussions

Obtain knowledge and practical application experience needed for validating software for use in medical device quality management systems. 

Oriel STAT A MATRIX’s Goal

Help our life science customers meet regulatory requirements, boost efficiency, and improve patient outcomes

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